An Study Investigating Nic's Keto Diet on Cardiovascular Health in Healthy Adults With Mildly Elevated LDL Levels

Sponsor

TRC GEN+ managed by Trans Russian co Cy (Other)

Overall Status

Completed

CT.gov ID

NCT04195594

Collaborator

KGK Science Inc. (Industry)

Enrollment

Location

Arm

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The present study will investigate the effects of Nic's Ketogenic diet, comprised of 70% fat, 5% carbohydrate, and 25% protein on middle-aged males and females with mid-range elevated LDL. With the mixed evidence on the causative effect of LDL cholesterol on increased cardiovascular health risk, further studies are warranted to examine the relation of elevated LDL and other biomarkers of cardiovascular health in response to a lifestyle intervention. Furthermore, this study will investigate weight loss and body composition changes with adherence to this dietary intervention over a 140-day period. In this study the efficacy of Nic's Ketogenic diet on weight loss and biomarkers of cardiovascular health will be examined.

Condition or Disease	Intervention/Treatment	Phase
Ketogenic Dieting Healthy	Other: Nic's Keto Diet	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Open-LabelOpen-Label

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

An Open Label Study to Investigate the Efficacy of Nic's Keto Diet on Cardiovascular Health in Healthy Adults With Mildly Elevated LDL Levels

Actual Study Start Date :

Jan 14, 2020

Actual Primary Completion Date :

Oct 13, 2020

Actual Study Completion Date :

Oct 13, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nic's Keto Diet	Other: Nic's Keto Diet Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.

Arm

Intervention/Treatment

Experimental: Nic's Keto Diet

Other: Nic's Keto Diet

Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.

Outcome Measures

Primary Outcome Measures

Changes to Body Fat Percentage as Assessed by DEXA Scan From Baseline to Day 70 Following Nic's Keto Diet [70 days]
The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 70.
Changes to Muscle Mass Percentage as Assessed by DEXA Scan From Baseline to Day 70 Following Nic's Keto Diet [70 days]
The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 70.
Changes to Body Fat Percentage as Assessed by DEXA Scan From Baseline to Day 140 Following Nic's Keto Diet [140 days]
The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 140.
Changes to Muscle Mass Percentage as Assessed by DEXA Scan From Baseline to Day 140 Following Nic's Keto Diet [140 days]
The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 140.
Changes to Weight as Assessed by BMI From Baseline to Day 70 Following Nic's Keto Diet [70 days]
Changes to weight as assessed by BMI was reported at baseline and compared to day 70.
Changes to Weight as Assessed by BMI From Baseline to Day 140 Following Nic's Keto Diet [140 days]
Changes to weight as assessed by BMI was reported at baseline and compared to day 140.

Secondary Outcome Measures

The Change in Inflammation, as Assessed by the Change in Erythrocyte Sedimentation Rate (ESR) Following Nic's Keto Diet for 140 Days [140 days]
The change in inflammation, as assessed by the change in erythrocyte sedimentation rate (ESR) following Nic's Keto Diet was reported at 140 days.
The Change in Inflammation, as Assessed by the Change in C-reactive Protein (CRP) Following Nic's Keto Diet for 140 Days [140 days]
The change in inflammation, as assessed by the change in C-reactive protein (CRP) following Nic's Keto Diet was reported at 140 days.
Changes to Weight From Baseline to Day 28 Following Nic's Keto Diet [28 days]
Changes to weight from baseline were reported and compared to day 28 following Nic's Keto Diet.
Changes to Weight From Baseline to Day 56 Following Nic's Keto Diet [56 days]
Changes to weight from baseline were reported and compared to day 56 following Nic's Keto Diet.
Changes to Weight From Baseline to Day 84 Following Nic's Keto Diet [84 days]
Changes to weight from baseline were reported and compared to day 84 following Nic's Keto Diet.
Changes to Weight From Baseline to Day 112 Following Nic's Keto Diet [112 days]
Changes to weight from baseline were reported and compared to day 112 following Nic's Keto Diet.
Changes to Systolic Blood Pressure From Baseline to Day 28 Following Nic's Keto Diet [28 days]
Changes to systolic blood pressure from baseline were reported and compared to day 28 following Nic's Keto Diet.
Changes to Systolic Blood Pressure From Baseline to Day 56 Following Nic's Keto Diet [56 days]
Changes to systolic blood pressure from baseline were reported and compared to day 56 following Nic's Keto Diet.
Changes to Systolic Blood Pressure From Baseline to Day 84 Following Nic's Keto Diet [84 days]
Changes to systolic blood pressure from baseline were reported and compared to day 84 following Nic's Keto Diet.
Changes to Systolic Blood Pressure From Baseline to Day 112 Following Nic's Keto Diet [112 days]
Changes to systolic blood pressure from baseline were reported and compared to day 112 following Nic's Keto Diet.
Changes to Systolic Blood Pressure From Baseline to Day 140 Following Nic's Keto Diet [140 days]
Changes to systolic blood pressure from baseline were reported and compared to day 140 following Nic's Keto Diet.
Changes to Total Cholesterol From Baseline to Day 28 Following Nic's Keto Diet [28 days]
Changes to total cholesterol were reported from baseline and compared to day 28 following Nic's Keto diet using blood analysis (units in mmol/L)
Changes to Triglyceride Level From Baseline to Day 28 Following Nic's Keto Diet [28 days]
Changes to triglyceride level were reported from baseline and compared to day 28 following Nic's Keto diet using blood analysis (units in mmol/L).
Changes to HDL-Cholesterol From Baseline to Day 28 Following Nic's Keto Diet [28 days]
Changes to HDL-cholesterol from baseline to day 28 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Changes to LDL-Cholesterol From Baseline to Day 28 Following Nic's Keto Diet [28 days]
Changes to LDL-cholesterol from baseline to day 28 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Changes to Total Cholesterol From Baseline to Day 56 Following Nic's Keto Diet [56 days]
Changes to total cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Changes to Triglyceride Level From Baseline to Day 56 Following Nic's Keto Diet [56 days]
Changes to triglyceride level from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Changes to HDL-Cholesterol From Baseline to Day 56 Following Nic's Keto Diet [56 days]
Changes to HDL-Cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Changes to LDL-Cholesterol From Baseline to Day 56 Following Nic's Keto Diet [56 days]
Changes to LDL-Cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Changes to Total Cholesterol From Baseline to Day 84 Following Nic's Keto Diet [84 days]
Changes to total cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Changes to Triglyceride Level From Baseline to Day 84 Following Nic's Keto Diet [84 days]
Changes to triglyceride level from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Changes to HDL-Cholesterol From Baseline to Day 84 Following Nic's Keto Diet [84 days]
Changes to HDL-Cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Changes to LDL-Cholesterol From Baseline to Day 84 Following Nic's Keto Diet [84 days]
Changes to LDL-Cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Changes to Total Cholesterol From Baseline to Day 112 Following Nic's Keto Diet [112 days]
Changes to total cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Changes to Triglyceride Level From Baseline to Day 112 Following Nic's Keto Diet [112 days]
Changes to triglyceride level from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Changes to HDL-Cholesterol From Baseline to Day 112 Following Nic's Keto Diet [112 days]
Changes to HDL-Cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Changes to LDL-Cholesterol From Baseline to Day 112 Following Nic's Keto Diet [112 days]
Changes to LDL-Cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Changes to Total Cholesterol From Baseline to Day 140 Following Nic's Keto Diet [140 days]
Changes to total cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Changes to Triglyceride Level From Baseline to Day 140 Following Nic's Keto Diet [140 days]
Changes to triglyceride level from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Changes to HDL-Cholesterol From Baseline to Day 140 Following Nic's Keto Diet [140 days]
Changes to HDL-Cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Changes to LDL-Cholesterol From Baseline to Day 140 Following Nic's Keto Diet [140 days]
Changes to LDL-Cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Changes to HbA1c From Baseline to Day 140 Following Nic's Keto Diet [140 days]
Changes to HbA1c were reported at baseline and compared to day 140 following Nic's Keto Diet.
Changes to Fasting Glucose From Baseline to Day 140 Following Nic's Keto Diet [140 days]
Changes to fasting glucose were reported at baseline and compared to day 140 following Nic's Keto Diet.
Changes to Free Tri-iodothyronine (T3) From Baseline to Day 140 Following Nic's Keto Diet [140 days]
Changes to free tri-iodothyronine (T3) were reported at baseline and compared to day 140 following Nic's Keto Diet.
Changes to Weight From Baseline to Day 70 Following Nic's Keto Diet [70 days]
Changes to weight were reported from baseline and compared to day 70 following Nic's Keto Diet.
Changes to Weight From Baseline to Day 140 Following Nic's Keto Diet [140 days]
Changes to weight were reported from baseline and compared to Day 140 following Nic's Keto Diet.
Changes to Systolic Blood Pressure From Baseline to Day 70 Following Nic's Keto Diet [70 days]
Changes to systolic blood pressure were reported from baseline and compared to Day 70 following Nic's Keto Diet.
Changes to Diastolic Blood Pressure From Baseline to Day 28 Following Nic's Keto Diet [28 days]
Changes to diastolic blood pressure were reported from baseline and compared to Day 28 following Nic's Keto Diet.
Changes to Diastolic Blood Pressure From Baseline to Day 56 Following Nic's Keto Diet [56 days]
Changes to diastolic blood pressure were reported from baseline and compared to Day 56 following Nic's Keto Diet.
Changes to Diastolic Blood Pressure From Baseline to Day 70 Following Nic's Keto Diet [70 days]
Changes to diastolic blood pressure were reported from baseline and compared to Day 70 following Nic's Keto Diet.
Changes to Diastolic Blood Pressure From Baseline to Day 84 Following Nic's Keto Diet [84 days]
Changes to diastolic blood pressure were reported from baseline and compared to Day 84 following Nic's Keto Diet.
Changes to Diastolic Blood Pressure From Baseline to Day 112 Following Nic's Keto Diet [112 days]
Changes to diastolic blood pressure were reported from baseline and compared to Day 112 following Nic's Keto Diet.
Changes to Diastolic Blood Pressure From Baseline to Day 140 Following Nic's Keto Diet [140 days]
Changes to diastolic blood pressure were reported from baseline and compared to Day 140 following Nic's Keto Diet.

Other Outcome Measures

Number of Pre-emergent and Post-emergent Adverse Events [140 days]
Number of pre-emergent and post-emergent adverse events (AEs)
Number of Participants With Abnormal Electrocardiogram (ECG) Readings After 70 Days Following Nic's Keto Diet [70 days]
ECG reports will be analysed after 70 days of following Nic's Keto Diet and compared to baseline. All ECGs will be assessed by the Qualified Investigator on a case-by-case basis to determine if they were normal or abnormal based on the full clinical picture and patient details. Number of participants with clinically relevant abnormal ECGs will be recorded.
Number of Participants With Abnormal Electrocardiogram (ECG) Readings After 140 Days Following Nic's Keto Diet [140 days]
ECG reports will be analysed after 140 days of following Nic's Keto Diet and compared to baseline. All ECGs will be assessed by the Qualified Investigator on a case-by-case basis to determine if they were normal or abnormal based on the full clinical picture and patient details. Number of participants with clinically relevant abnormal ECGs will be recorded.
Change in Heart Rate After 140 Days of Following Nic's Keto Diet [140 days]
Changes in heart rate after 140 days of following Nic's Keto Diet and compared to baseline.
Change in Body Mass Index (BMI) After 140 Days of Following Nic's Keto Diet [140 days]
Change in Body Mass Index (BMI) after 140 days of following Nic's Keto Diet compared to baseline.
Change in Alanine Aminotransferase (ALT) After 140 Days of Following Nic's Keto Diet [140 days]
Change in alanine aminotransferase (ALT) after 140 days of following Nic's Keto Diet compared to baseline.
Change in Aspartate Aminotransferase (AST) After 140 Days of Following Nic's Keto Diet [140 days]
Change in aspartate aminotransferase (AST) after 140 days of following Nic's Keto Diet compared to baseline.
Change in Total Bilirubin After 140 Days of Following Nic's Keto Diet [140 days]
Change in total bilirubin after 140 days of following Nic's Keto Diet compared to baseline.
Change in Creatinine After 140 Days of Following Nic's Keto Diet [140 days]
Change in creatinine after 140 days of following Nic's Keto Diet compared to baseline.
Change in Sodium Electrolyte Levels After 140 Days of Following Nic's Keto Diet [140 days]
Change in sodium electrolyte levels after 140 days of following Nic's Keto Diet compared to baseline.
Change in Potassium Electrolyte Levels After 140 Days of Following Nic's Keto Diet [140 days]
Change in potassium electrolyte levels after 140 days of following Nic's Keto Diet
Change in Chloride Electrolyte Levels After 140 Days of Following Nic's Keto Diet [140 days]
Change in chloride electrolyte levels after 140 days of following Nic's Keto Diet compared to baseline.
Change in Phosphorus Electrolyte Levels After 140 Days of Following Nic's Keto Diet [140 days]
Change in phosphorus electrolyte levels after 140 days of following Nic's Keto Diet compared to baseline.
Change in Estimated Glomerular Filtration Rate (eGFR) After 140 Days of Following Nic's Keto Diet [140 days]
Change in estimated glomerular filtration rate (eGFR) after 140 days of following Nic's Keto Diet compared to baseline.
Change in Amount of Neutrophils After 140 Days of Following Nic's Keto Diet [140 days]
Change in amount of neutrophils after 140 days of following Nic's Keto Diet compared to baseline.
Change in Amount of Lymphocytes After 140 Days of Following Nic's Keto Diet [140 days]
Change in amount of lymphocytes after 140 days of following Nic's Keto Diet compared to baseline.
Change in Amount of Monocytes After 140 Days of Following Nic's Keto Diet [140 days]
Change in amount of monocytes after 140 days of following Nic's Keto Diet compared to baseline.
Change in Amount of Eosinophils After 140 Days of Following Nic's Keto Diet [140 days]
Change in amount of eosinophils after 140 days of following Nic's Keto Diet compared to baseline.
Change in Amount of Basophils After 140 Days of Following Nic's Keto Diet [140 days]
Change in amount of basophils after 140 days of following Nic's Keto Diet compared to baseline.
Change in Red Blood Cell (RBC) Count After 140 Days of Following Nic's Keto Diet [140 days]
Change in red blood cell (RBC) count after 140 days of following Nic's Keto Diet compared to baseline.
Change in Hemoglobin Levels After 140 Days of Following Nic's Keto Diet [140 days]
Change in hemoglobin levels after 140 days of following Nic's Keto Diet compared to baseline.
Change in Hematocrit Levels After 140 Days of Following Nic's Keto Diet [140 days]
Change in hematocrit levels after 140 days of following Nic's Keto Diet compared to baseline.
Change in Platelet Count After 140 Days of Following Nic's Keto Diet [140 days]
Change in platelet count after 140 days of following Nic's Keto Diet compared to baseline.
Change in Mean Corpuscular Volume (MCV) After 140 Days of Following Nic's Keto Diet [140 days]
Change in mean corpuscular volume (MCV) after 140 days of following Nic's Keto Diet compared to baseline.
Change in Mean Corpuscular Hemoglobin (MCH) After 140 Days of Following Nic's Keto Diet [140 days]
Change in mean corpuscular hemoglobin (MCH) after 140 days of following Nic's Keto Diet compared to baseline.
Change in Mean Corpuscular Hemoglobin Concentration (MCHC) After 140 Days of Following Nic's Keto Diet [140 days]
Change in mean corpuscular hemoglobin concentration (MCHC) after 140 days of following Nic's Keto Diet compared to baseline.
Change in Red Cell Distribution Width (RDW) After 140 Days of Following Nic's Keto Diet [140 days]
Change in red cell distribution width (RDW) after 140 days of following Nic's Keto Diet compared to baseline.
Change in Mean Platelet Volume (MPV) After 140 Days of Following Nic's Keto Diet [140 days]
Change in mean platelet volume (MPV) after 140 days of following Nic's Keto Diet compared to baseline.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Provided voluntary, written, informed consent to participate in study
Males and females between 30 and 55 years of age
BMI between 20.0 to 29.9 kg/m2, inclusive
Female participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, total endometrial ablation) Or,

Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. Acceptable methods of birth control include:

Non hormonal contraceptives
Double-barrier method
Intrauterine devices
Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
Vasectomy of partner at least 6 months prior to screening

Subjects with mid-range (2.5-4.1mmol/L or 100-159 mg/dL) elevated LDL-C levels
Agrees to maintain current level of physical activity throughout the study
Willingness to complete all questionnaires, records, and diaries and assessments associated with the study and to complete all clinic visits.
Healthy as determined by medical history, laboratory results, and as assessed by Qualified Investigator (QI)

Exclusion Criteria:

Women who are pregnant, breast feeding, or planning to become pregnant during the course of the trial
Women who are menopausal or post-menopausal
Currently following a diet (i.e. Ketogenic Diet, low-carbohydrate diet)
Subjects with high TSH level (>4.5mU/L) or Self reported pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
Participants with type I or II Diabetes Mellitus
Cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable.
Participants with previous or current pathology of the pancreas
Current or history of Gastroesophageal reflux disease (GERD) or any significant disease of the gastrointestinal tract
Self reported hypertension or on hypertensives.
Significant cardiovascular event in the past 6 months as assessed by the QI.
Major surgery in the past 3 months or individuals who have planned surgery during the course of the trial. Participants with minor surgery will be considered on a case-by-case basis by the QI
Gastric bypass surgery
Individuals with an autoimmune disease or are immune-compromised
Self reported HIV-, Hepatitis B- and/or C-positive diagnosis
History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones symptom free for 6 months
Self reported medical or neuropsychological condition and/or cognitive impairment that, in the QI's opinion, could interfere with study participation
Self reported blood/bleeding disorders as per QI
Current use of prescribed medications listed in Section 7.3.1
Current use of over-the-counter medications, supplements, foods, and/or drinks listed in Section 7.3.2
Alcohol or drug abuse within the last 12 months
High alcohol intake (>2 standard drinks per day or >10 standard drinks per week)
Clinically significant abnormal laboratory results at screening as assessed by the QI
Metal implants that may affect the DEXA scan results will be assessed on case-by-case basis by the QI
Blood donation 30 days prior to screening, during the study, or a planned donation within 30-days of the last study visit
Participation in a clinical research trial within 30 days of study initiation
Individuals who are unable to give informed consent
Any other active or unstable medical condition, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or may pose significant risk to the participant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KGK Science Inc.	London	Ontario	Canada	N6A 5R8

Sponsors and Collaborators

TRC GEN+ managed by Trans Russian co Cy
KGK Science Inc.

Investigators

Principal Investigator: David Crowley, MD, KGK Science Inc.

Study Documents (Full-Text)

Study Protocol and Statistical Analysis Plan - Oct 7, 2019

More Information

Publications

None provided.

Responsible Party:

TRC GEN+ managed by Trans Russian co Cy

ClinicalTrials.gov Identifier:

NCT04195594

Other Study ID Numbers:

19KLHT

First Posted:

Dec 12, 2019

Last Update Posted:

May 4, 2021

Last Verified:

Apr 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by TRC GEN+ managed by Trans Russian co Cy

Ketogenic Diet

Nic's keto diet

Cardiovascular health

Elevated LDL levels

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Period Title: Overall Study
STARTED	14
COMPLETED	11
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Overall Participants	14
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	14 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.86 (7.36)
Sex: Female, Male (Count of Participants)
Female	7 50%
Male	7 50%
Race/Ethnicity, Customized (Count of Participants)
Eastern European White	4 28.6%
South American	3 21.4%
South Asian	1 7.1%
Western European White	6 42.9%
Region of Enrollment (participants) [Number]
Canada	14 100%

Outcome Measures

1. Primary Outcome

Title	Changes to Body Fat Percentage as Assessed by DEXA Scan From Baseline to Day 70 Following Nic's Keto Diet
Description	The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 70.
Time Frame	70 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	12
Mean (Standard Deviation) [percentage of body fat]	-2.25 (2.48)

2. Primary Outcome

Title	Changes to Muscle Mass Percentage as Assessed by DEXA Scan From Baseline to Day 70 Following Nic's Keto Diet
Description	The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 70.
Time Frame	70 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	12
Mean (Standard Deviation) [percentage of muscle mass]	2.24 (2.49)

3. Primary Outcome

Title	Changes to Body Fat Percentage as Assessed by DEXA Scan From Baseline to Day 140 Following Nic's Keto Diet
Description	The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 140.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	11
Mean (Standard Deviation) [percentage of body fat]	-4.41 (4.04)

4. Primary Outcome

Title	Changes to Muscle Mass Percentage as Assessed by DEXA Scan From Baseline to Day 140 Following Nic's Keto Diet
Description	The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 140.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	11
Mean (Standard Deviation) [percentage of muscle mass]	4.38 (4.03)

5. Primary Outcome

Title	Changes to Weight as Assessed by BMI From Baseline to Day 70 Following Nic's Keto Diet
Description	Changes to weight as assessed by BMI was reported at baseline and compared to day 70.
Time Frame	70 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	12
Mean (Standard Deviation) [kg/m^2]	-1.64 (0.83)

6. Primary Outcome

Title	Changes to Weight as Assessed by BMI From Baseline to Day 140 Following Nic's Keto Diet
Description	Changes to weight as assessed by BMI was reported at baseline and compared to day 140.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	11
Mean (Standard Deviation) [kg/m^2]	-2.82 (1.49)

7. Secondary Outcome

Title	The Change in Inflammation, as Assessed by the Change in Erythrocyte Sedimentation Rate (ESR) Following Nic's Keto Diet for 140 Days
Description	The change in inflammation, as assessed by the change in erythrocyte sedimentation rate (ESR) following Nic's Keto Diet was reported at 140 days.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	11
Mean (Standard Deviation) [mm/hr]	0.36 (4.43)

8. Secondary Outcome

Title	The Change in Inflammation, as Assessed by the Change in C-reactive Protein (CRP) Following Nic's Keto Diet for 140 Days
Description	The change in inflammation, as assessed by the change in C-reactive protein (CRP) following Nic's Keto Diet was reported at 140 days.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	11
Mean (Standard Deviation) [mg/L]	-0.71 (2.10)

9. Secondary Outcome

Title	Changes to Weight From Baseline to Day 28 Following Nic's Keto Diet
Description	Changes to weight from baseline were reported and compared to day 28 following Nic's Keto Diet.
Time Frame	28 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	13
Mean (Standard Deviation) [kg]	-3.02 (2.09)

10. Secondary Outcome

Title	Changes to Weight From Baseline to Day 56 Following Nic's Keto Diet
Description	Changes to weight from baseline were reported and compared to day 56 following Nic's Keto Diet.
Time Frame	56 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	12
Mean (Standard Deviation) [kg]	-4.47 (2.79)

11. Secondary Outcome

Title	Changes to Weight From Baseline to Day 84 Following Nic's Keto Diet
Description	Changes to weight from baseline were reported and compared to day 84 following Nic's Keto Diet.
Time Frame	84 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	11
Mean (Standard Deviation) [kg]	-5.58 (3.07)

12. Secondary Outcome

Title	Changes to Weight From Baseline to Day 112 Following Nic's Keto Diet
Description	Changes to weight from baseline were reported and compared to day 112 following Nic's Keto Diet.
Time Frame	112 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	11
Mean (Standard Deviation) [kg]	-6.43 (3.93)

13. Secondary Outcome

Title	Changes to Systolic Blood Pressure From Baseline to Day 28 Following Nic's Keto Diet
Description	Changes to systolic blood pressure from baseline were reported and compared to day 28 following Nic's Keto Diet.
Time Frame	28 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	13
Mean (Standard Deviation) [mm Hg]	1.23 (7.79)

14. Secondary Outcome

Title	Changes to Systolic Blood Pressure From Baseline to Day 56 Following Nic's Keto Diet
Description	Changes to systolic blood pressure from baseline were reported and compared to day 56 following Nic's Keto Diet.
Time Frame	56 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	12
Mean (Standard Deviation) [mm Hg]	-3.06 (6.62)

15. Secondary Outcome

Title	Changes to Systolic Blood Pressure From Baseline to Day 84 Following Nic's Keto Diet
Description	Changes to systolic blood pressure from baseline were reported and compared to day 84 following Nic's Keto Diet.
Time Frame	84 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	11
Mean (Standard Deviation) [mm Hg]	-2.73 (8.30)

16. Secondary Outcome

Title	Changes to Systolic Blood Pressure From Baseline to Day 112 Following Nic's Keto Diet
Description	Changes to systolic blood pressure from baseline were reported and compared to day 112 following Nic's Keto Diet.
Time Frame	112 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	11
Mean (Standard Deviation) [mm Hg]	-3.85 (7.58)

17. Secondary Outcome

Title	Changes to Systolic Blood Pressure From Baseline to Day 140 Following Nic's Keto Diet
Description	Changes to systolic blood pressure from baseline were reported and compared to day 140 following Nic's Keto Diet.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	11
Mean (Standard Deviation) [mm Hg]	-6.52 (9.53)

18. Secondary Outcome

Title	Changes to Total Cholesterol From Baseline to Day 28 Following Nic's Keto Diet
Description	Changes to total cholesterol were reported from baseline and compared to day 28 following Nic's Keto diet using blood analysis (units in mmol/L)
Time Frame	28 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	13
Mean (Standard Deviation) [mmol/L]	0.87 (1.01)

19. Secondary Outcome

Title	Changes to Triglyceride Level From Baseline to Day 28 Following Nic's Keto Diet
Description	Changes to triglyceride level were reported from baseline and compared to day 28 following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame	28 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	13
Mean (Standard Deviation) [mmol/L]	0.04 (0.62)

20. Secondary Outcome

Title	Changes to HDL-Cholesterol From Baseline to Day 28 Following Nic's Keto Diet
Description	Changes to HDL-cholesterol from baseline to day 28 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame	28 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	13
Mean (Standard Deviation) [mmol/L]	-0.04 (0.27)

21. Secondary Outcome

Title	Changes to LDL-Cholesterol From Baseline to Day 28 Following Nic's Keto Diet
Description	Changes to LDL-cholesterol from baseline to day 28 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame	28 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	13
Mean (Standard Deviation) [mmol/L]	0.89 (0.84)

22. Secondary Outcome

Title	Changes to Total Cholesterol From Baseline to Day 56 Following Nic's Keto Diet
Description	Changes to total cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame	56 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	13
Mean (Standard Deviation) [mmol/L]	0.91 (0.97)

23. Secondary Outcome

Title	Changes to Triglyceride Level From Baseline to Day 56 Following Nic's Keto Diet
Description	Changes to triglyceride level from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame	56 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	13
Mean (Standard Deviation) [mmol/L]	-0.07 (0.67)

24. Secondary Outcome

Title	Changes to HDL-Cholesterol From Baseline to Day 56 Following Nic's Keto Diet
Description	Changes to HDL-Cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame	56 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	13
Mean (Standard Deviation) [mmol/L]	0.01 (0.28)

25. Secondary Outcome

Title	Changes to LDL-Cholesterol From Baseline to Day 56 Following Nic's Keto Diet
Description	Changes to LDL-Cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame	56 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	13
Mean (Standard Deviation) [mmol/L]	0.93 (0.87)

26. Secondary Outcome

Title	Changes to Total Cholesterol From Baseline to Day 84 Following Nic's Keto Diet
Description	Changes to total cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame	84 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	12
Mean (Standard Deviation) [mmol/L]	1.13 (1.21)

27. Secondary Outcome

Title	Changes to Triglyceride Level From Baseline to Day 84 Following Nic's Keto Diet
Description	Changes to triglyceride level from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame	84 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	12
Mean (Standard Deviation) [mmol/L]	-0.11 (0.57)

28. Secondary Outcome

Title	Changes to HDL-Cholesterol From Baseline to Day 84 Following Nic's Keto Diet
Description	Changes to HDL-Cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame	84 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	12
Mean (Standard Deviation) [mmol/L]	0.02 (0.32)

29. Secondary Outcome

Title	Changes to LDL-Cholesterol From Baseline to Day 84 Following Nic's Keto Diet
Description	Changes to LDL-Cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame	84 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	12
Mean (Standard Deviation) [mmol/L]	1.16 (1.12)

30. Secondary Outcome

Title	Changes to Total Cholesterol From Baseline to Day 112 Following Nic's Keto Diet
Description	Changes to total cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame	112 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	11
Mean (Standard Deviation) [mmol/L]	1.01 (1.31)

31. Secondary Outcome

Title	Changes to Triglyceride Level From Baseline to Day 112 Following Nic's Keto Diet
Description	Changes to triglyceride level from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame	112 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	11
Mean (Standard Deviation) [mmol/L]	-0.16 (0.55)

32. Secondary Outcome

Title	Changes to HDL-Cholesterol From Baseline to Day 112 Following Nic's Keto Diet
Description	Changes to HDL-Cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame	112 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	11
Mean (Standard Deviation) [mmol/L]	0.10 (0.38)

33. Secondary Outcome

Title	Changes to LDL-Cholesterol From Baseline to Day 112 Following Nic's Keto Diet
Description	Changes to LDL-Cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame	112 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	11
Mean (Standard Deviation) [mmol/L]	0.99 (1.17)

34. Secondary Outcome

Title	Changes to Total Cholesterol From Baseline to Day 140 Following Nic's Keto Diet
Description	Changes to total cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	11
Mean (Standard Deviation) [mmol/L]	1.06 (1.10)

35. Secondary Outcome

Title	Changes to Triglyceride Level From Baseline to Day 140 Following Nic's Keto Diet
Description	Changes to triglyceride level from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	11
Mean (Standard Deviation) [mmol/L]	-0.23 (0.41)

36. Secondary Outcome

Title	Changes to HDL-Cholesterol From Baseline to Day 140 Following Nic's Keto Diet
Description	Changes to HDL-Cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	11
Mean (Standard Deviation) [mmol/L]	0.15 (0.27)

37. Secondary Outcome

Title	Changes to LDL-Cholesterol From Baseline to Day 140 Following Nic's Keto Diet
Description	Changes to LDL-Cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	11
Mean (Standard Deviation) [mmol/L]	1.02 (0.94)

38. Secondary Outcome

Title	Changes to HbA1c From Baseline to Day 140 Following Nic's Keto Diet
Description	Changes to HbA1c were reported at baseline and compared to day 140 following Nic's Keto Diet.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	11
Mean (Standard Deviation) [percent of Glycosylated Haemoglobin]	-0.22 (0.18)

39. Secondary Outcome

Title	Changes to Fasting Glucose From Baseline to Day 140 Following Nic's Keto Diet
Description	Changes to fasting glucose were reported at baseline and compared to day 140 following Nic's Keto Diet.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	11
Mean (Standard Deviation) [mmol/L]	-0.06 (0.37)

40. Secondary Outcome

Title	Changes to Free Tri-iodothyronine (T3) From Baseline to Day 140 Following Nic's Keto Diet
Description	Changes to free tri-iodothyronine (T3) were reported at baseline and compared to day 140 following Nic's Keto Diet.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	11
Mean (Standard Deviation) [pmol/L]	-0.85 (0.55)

41. Secondary Outcome

Title	Changes to Weight From Baseline to Day 70 Following Nic's Keto Diet
Description	Changes to weight were reported from baseline and compared to day 70 following Nic's Keto Diet.
Time Frame	70 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	12
Mean (Standard Deviation) [kg]	-4.90 (2.66)

42. Secondary Outcome

Title	Changes to Weight From Baseline to Day 140 Following Nic's Keto Diet
Description	Changes to weight were reported from baseline and compared to Day 140 following Nic's Keto Diet.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	11
Mean (Standard Deviation) [kg]	-8.55 (4.74)

43. Secondary Outcome

Title	Changes to Systolic Blood Pressure From Baseline to Day 70 Following Nic's Keto Diet
Description	Changes to systolic blood pressure were reported from baseline and compared to Day 70 following Nic's Keto Diet.
Time Frame	70 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	12
Mean (Standard Deviation) [mm Hg]	-3.72 (7.96)

44. Secondary Outcome

Title	Changes to Diastolic Blood Pressure From Baseline to Day 28 Following Nic's Keto Diet
Description	Changes to diastolic blood pressure were reported from baseline and compared to Day 28 following Nic's Keto Diet.
Time Frame	28 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	13
Mean (Standard Deviation) [mm Hg]	3.23 (6.06)

45. Secondary Outcome

Title	Changes to Diastolic Blood Pressure From Baseline to Day 56 Following Nic's Keto Diet
Description	Changes to diastolic blood pressure were reported from baseline and compared to Day 56 following Nic's Keto Diet.
Time Frame	56 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	12
Mean (Standard Deviation) [mm Hg]	0.44 (5.13)

46. Secondary Outcome

Title	Changes to Diastolic Blood Pressure From Baseline to Day 70 Following Nic's Keto Diet
Description	Changes to diastolic blood pressure were reported from baseline and compared to Day 70 following Nic's Keto Diet.
Time Frame	70 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	12
Mean (Standard Deviation) [mm Hg]	-0.14 (6.81)

47. Secondary Outcome

Title	Changes to Diastolic Blood Pressure From Baseline to Day 84 Following Nic's Keto Diet
Description	Changes to diastolic blood pressure were reported from baseline and compared to Day 84 following Nic's Keto Diet.
Time Frame	84 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	11
Mean (Standard Deviation) [mm Hg]	-2.33 (7.34)

48. Secondary Outcome

Title	Changes to Diastolic Blood Pressure From Baseline to Day 112 Following Nic's Keto Diet
Description	Changes to diastolic blood pressure were reported from baseline and compared to Day 112 following Nic's Keto Diet.
Time Frame	112 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	11
Mean (Standard Deviation) [mm Hg]	-1.21 (5.25)

49. Secondary Outcome

Title	Changes to Diastolic Blood Pressure From Baseline to Day 140 Following Nic's Keto Diet
Description	Changes to diastolic blood pressure were reported from baseline and compared to Day 140 following Nic's Keto Diet.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	11
Mean (Standard Deviation) [mm Hg]	0.30 (6.60)

50. Other Pre-specified Outcome

Title	Number of Pre-emergent and Post-emergent Adverse Events
Description	Number of pre-emergent and post-emergent adverse events (AEs)
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
Safety population

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	14
Number [events]	44

51. Other Pre-specified Outcome

Title	Number of Participants With Abnormal Electrocardiogram (ECG) Readings After 70 Days Following Nic's Keto Diet
Description	ECG reports will be analysed after 70 days of following Nic's Keto Diet and compared to baseline. All ECGs will be assessed by the Qualified Investigator on a case-by-case basis to determine if they were normal or abnormal based on the full clinical picture and patient details. Number of participants with clinically relevant abnormal ECGs will be recorded.
Time Frame	70 days

Outcome Measure Data

Analysis Population Description
Safety population

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	14
Number [participants]	0 0%

52. Other Pre-specified Outcome

Title	Number of Participants With Abnormal Electrocardiogram (ECG) Readings After 140 Days Following Nic's Keto Diet
Description	ECG reports will be analysed after 140 days of following Nic's Keto Diet and compared to baseline. All ECGs will be assessed by the Qualified Investigator on a case-by-case basis to determine if they were normal or abnormal based on the full clinical picture and patient details. Number of participants with clinically relevant abnormal ECGs will be recorded.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
Safety population

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	14
Number [participants]	0 0%

53. Other Pre-specified Outcome

Title	Change in Heart Rate After 140 Days of Following Nic's Keto Diet
Description	Changes in heart rate after 140 days of following Nic's Keto Diet and compared to baseline.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	11
Mean (Standard Deviation) [bpm]	0.61 (9.06)

54. Other Pre-specified Outcome

Title	Change in Body Mass Index (BMI) After 140 Days of Following Nic's Keto Diet
Description	Change in Body Mass Index (BMI) after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	11
Mean (Standard Deviation) [kg/m^2]	-2.82 (1.49)

55. Other Pre-specified Outcome

Title	Change in Alanine Aminotransferase (ALT) After 140 Days of Following Nic's Keto Diet
Description	Change in alanine aminotransferase (ALT) after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	13
Mean (Standard Deviation) [U/L]	-1.01 (7.82)

56. Other Pre-specified Outcome

Title	Change in Aspartate Aminotransferase (AST) After 140 Days of Following Nic's Keto Diet
Description	Change in aspartate aminotransferase (AST) after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	13
Mean (Standard Deviation) [U/L]	0.08 (6.95)

57. Other Pre-specified Outcome

Title	Change in Total Bilirubin After 140 Days of Following Nic's Keto Diet
Description	Change in total bilirubin after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	13
Mean (Standard Deviation) [µmol/L]	0.23 (5.63)

58. Other Pre-specified Outcome

Title	Change in Creatinine After 140 Days of Following Nic's Keto Diet
Description	Change in creatinine after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	13
Mean (Standard Deviation) [µmol/L]	3.77 (9.58)

59. Other Pre-specified Outcome

Title	Change in Sodium Electrolyte Levels After 140 Days of Following Nic's Keto Diet
Description	Change in sodium electrolyte levels after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	13
Mean (Standard Deviation) [mmol/L]	0.92 (2.33)

60. Other Pre-specified Outcome

Title	Change in Potassium Electrolyte Levels After 140 Days of Following Nic's Keto Diet
Description	Change in potassium electrolyte levels after 140 days of following Nic's Keto Diet
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	13
Mean (Standard Deviation) [mmol/L]	-0.12 (0.46)

61. Other Pre-specified Outcome

Title	Change in Chloride Electrolyte Levels After 140 Days of Following Nic's Keto Diet
Description	Change in chloride electrolyte levels after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	13
Mean (Standard Deviation) [mmol/L]	-0.23 (1.92)

62. Other Pre-specified Outcome

Title	Change in Phosphorus Electrolyte Levels After 140 Days of Following Nic's Keto Diet
Description	Change in phosphorus electrolyte levels after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	13
Mean (Standard Deviation) [mmol/L]	0.14 (0.16)

63. Other Pre-specified Outcome

Title	Change in Estimated Glomerular Filtration Rate (eGFR) After 140 Days of Following Nic's Keto Diet
Description	Change in estimated glomerular filtration rate (eGFR) after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	13
Mean (Standard Deviation) [mL/min/1.73m^2]	-5.00 (11.08)

64. Other Pre-specified Outcome

Title	Change in Amount of Neutrophils After 140 Days of Following Nic's Keto Diet
Description	Change in amount of neutrophils after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	13
Mean (Standard Deviation) [x10^9 neutrophils/L]	-0.53 (1.21)

65. Other Pre-specified Outcome

Title	Change in Amount of Lymphocytes After 140 Days of Following Nic's Keto Diet
Description	Change in amount of lymphocytes after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	13
Mean (Standard Deviation) [x10^9 lymphocytes/L]	-0.17 (0.47)

66. Other Pre-specified Outcome

Title	Change in Amount of Monocytes After 140 Days of Following Nic's Keto Diet
Description	Change in amount of monocytes after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	13
Mean (Standard Deviation) [x10^9 monocytes/L]	-0.06 (0.14)

67. Other Pre-specified Outcome

Title	Change in Amount of Eosinophils After 140 Days of Following Nic's Keto Diet
Description	Change in amount of eosinophils after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	13
Mean (Standard Deviation) [x10^9 eosinophils/L]	0.00 (0.08)

68. Other Pre-specified Outcome

Title	Change in Amount of Basophils After 140 Days of Following Nic's Keto Diet
Description	Change in amount of basophils after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	13
Mean (Standard Deviation) [x10^9 basophils/L]	0.00 (0.04)

69. Other Pre-specified Outcome

Title	Change in Red Blood Cell (RBC) Count After 140 Days of Following Nic's Keto Diet
Description	Change in red blood cell (RBC) count after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	13
Mean (Standard Deviation) [x10^12 RBC/L]	-0.05 (0.20)

70. Other Pre-specified Outcome

Title	Change in Hemoglobin Levels After 140 Days of Following Nic's Keto Diet
Description	Change in hemoglobin levels after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	13
Mean (Standard Deviation) [g/L]	-1.46 (6.31)

71. Other Pre-specified Outcome

Title	Change in Hematocrit Levels After 140 Days of Following Nic's Keto Diet
Description	Change in hematocrit levels after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	13
Mean (Standard Deviation) [l/l]	0.00 (0.02)

72. Other Pre-specified Outcome

Title	Change in Platelet Count After 140 Days of Following Nic's Keto Diet
Description	Change in platelet count after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	13
Mean (Standard Deviation) [x10^9 platelets/L]	15.85 (30.56)

73. Other Pre-specified Outcome

Title	Change in Mean Corpuscular Volume (MCV) After 140 Days of Following Nic's Keto Diet
Description	Change in mean corpuscular volume (MCV) after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	13
Mean (Standard Deviation) [fl]	0.85 (1.41)

74. Other Pre-specified Outcome

Title	Change in Mean Corpuscular Hemoglobin (MCH) After 140 Days of Following Nic's Keto Diet
Description	Change in mean corpuscular hemoglobin (MCH) after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	13
Mean (Standard Deviation) [pg]	-0.08 (0.95)

75. Other Pre-specified Outcome

Title	Change in Mean Corpuscular Hemoglobin Concentration (MCHC) After 140 Days of Following Nic's Keto Diet
Description	Change in mean corpuscular hemoglobin concentration (MCHC) after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	13
Mean (Standard Deviation) [g/L]	-3.69 (7.48)

76. Other Pre-specified Outcome

Title	Change in Red Cell Distribution Width (RDW) After 140 Days of Following Nic's Keto Diet
Description	Change in red cell distribution width (RDW) after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	13
Mean (Standard Deviation) [percentage of variation]	0.37 (0.71)

77. Other Pre-specified Outcome

Title	Change in Mean Platelet Volume (MPV) After 140 Days of Following Nic's Keto Diet
Description	Change in mean platelet volume (MPV) after 140 days of following Nic's Keto Diet compared to baseline.
Time Frame	140 days

Outcome Measure Data

Analysis Population Description
The analysis population takes into account participants that were withdrawn by the qualified investigator and/or those who were withdrawn at their own request.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Measure Participants	13
Mean (Standard Deviation) [fl]	-0.20 (0.26)

Adverse Events

	Nic's Keto Diet
Time Frame	140 days
Adverse Event Reporting Description	During the study, participants recorded AEs in their diary. At each visit, the participant was asked "have you experienced any difficulties or problems since I last saw you?" upon which answers (AEs) were documented in the study record and were classified as per the description, duration, intensity, frequency, and outcome. The qualified investigator assessed any AEs and decided causality.

Arm/Group Title	Nic's Keto Diet
Arm/Group Description	Nic's Keto Diet: Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
All Cause Mortality
	Affected / at Risk (%)	# Events
Total	0/14 (0%)
Serious Adverse Events
	Nic's Keto Diet
	Affected / at Risk (%)	# Events
Total	0/14 (0%)
Other (Not Including Serious) Adverse Events
	Nic's Keto Diet
	Affected / at Risk (%)	# Events
Total	10/14 (71.4%)
Endocrine disorders
Amenorrhoea	1/14 (7.1%)	1
Gastrointestinal disorders
Constipation	2/14 (14.3%)	4
Diarrhoea	2/14 (14.3%)	3
Vomiting	2/14 (14.3%)	2
Dyspepsia	1/14 (7.1%)	1
Nausea	1/14 (7.1%)	1
Oropharyngeal pain	1/14 (7.1%)	1
Abdominal discomfort	1/14 (7.1%)	1
General disorders
Malaise	2/14 (14.3%)	2
Infections and infestations
Nasopharyngitis	1/14 (7.1%)	1
Injury, poisoning and procedural complications
Limb injury	1/14 (7.1%)	1
Sunburn	1/14 (7.1%)	1
Investigations
Haemoglobin decreased	1/14 (7.1%)	1
Musculoskeletal and connective tissue disorders
Back pain	1/14 (7.1%)	1
Nervous system disorders
Headache	4/14 (28.6%)	7
Dizziness	2/14 (14.3%)	2
Insomnia	1/14 (7.1%)	1
Psychiatric disorders
Anxiety	1/14 (7.1%)	1
Insomnia	1/14 (7.1%)	1
Irritability	1/14 (7.1%)	1
Mood altered	1/14 (7.1%)	1
Sleep disorder	4/14 (28.6%)	4
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis	2/14 (14.3%)	2
Cough	1/14 (7.1%)	1
Skin and subcutaneous tissue disorders
Acne	1/14 (7.1%)	1
Vascular disorders
Vessel puncture site bruise	1/14 (7.1%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The PI is an employee of the CRO that conducted the study. The research agreement indicates that the data is the property of the sponsor and therefore they control the option for disclosing results.

Results Point of Contact

Name/Title	Nikolaos Tzenios
Organization	TRCGEN+ (managed by Trans Russian Co)
Phone	+447583902071
Email	Nicolas@trccolleges.com

Responsible Party:

TRC GEN+ managed by Trans Russian co Cy

ClinicalTrials.gov Identifier:

NCT04195594

Other Study ID Numbers:

19KLHT

First Posted:

Dec 12, 2019

Last Update Posted:

May 4, 2021

Last Verified:

Apr 1, 2021