The Safety and Efficacy of a Bone Broth Diet on Weight Loss in Obese Adults

Sponsor

Veyl Ventures LLC (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05740670

Collaborator

KGK Science Inc. (Industry)

100

Enrollment

Location

Arm

13.5

Anticipated Duration (Months)

7.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to investigate the safety and efficacy of a bone broth diet on weight loss in obese adults. The change in weight and body mass index (BMI) following the bone broth diet will be measured from baseline at Days 22 and 50. Additionally, the safety and tolerability of the bone broth diet will be measured by the occurrence of post-emergent adverse events (AEs).

Condition or Disease	Intervention/Treatment	Phase
Weight Loss	Other: Dr. Kellyann's Bone Broth	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-label Clinical Trial to Investigate the Safety and Efficacy of a Bone Broth Diet on Weight Loss in Obese Adults

Actual Study Start Date :

Jan 27, 2023

Anticipated Primary Completion Date :

Dec 18, 2023

Anticipated Study Completion Date :

Mar 14, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dr. Kellyann's Bone Broth During the bone broth phases, each week will be separated into 'fasting days' and 'feeding days'. There will be 2 non-consecutive fasting days and 5 feeding days per week. On fasting days, participants will be instructed to consume 1 packet of bone broth every 2 hours, for a total of 7 packets/day. On feeding days, participants will consume 3 meals/day, made up of 'Yes' foods portioned according to instructions provided in the Bone Broth Diet Quick Reference Guide and 1 packet of bone broth, twice a day, as snacks between meals. If a bone broth serving is missed participants are instructed to consume the serving as soon as they remember. Participants will be advised not to exceed 7servings of bone broth on fasting days and 2 servings on feeding days. During the maintenance phase, participants will not consume any bone broth.	Other: Dr. Kellyann's Bone Broth Participants will have two bone broth phases, each three weeks in length. Bone broth phases will be separated by a one-week maintenance phase. A one-week maintenance phase will also occur after the second bone broth phase. Each week of a broth phase will consist of five feeding days and five fasting days. On feeding days, participants will consume one packet of bone broth, twice each day, as snacks between meals. On fasting days, participants will consume one packet of bone broth every two hours for a total of seven packets each day.

Arm

Intervention/Treatment

Experimental: Dr. Kellyann's Bone Broth

During the bone broth phases, each week will be separated into 'fasting days' and 'feeding days'. There will be 2 non-consecutive fasting days and 5 feeding days per week. On fasting days, participants will be instructed to consume 1 packet of bone broth every 2 hours, for a total of 7 packets/day. On feeding days, participants will consume 3 meals/day, made up of 'Yes' foods portioned according to instructions provided in the Bone Broth Diet Quick Reference Guide and 1 packet of bone broth, twice a day, as snacks between meals. If a bone broth serving is missed participants are instructed to consume the serving as soon as they remember. Participants will be advised not to exceed 7servings of bone broth on fasting days and 2 servings on feeding days. During the maintenance phase, participants will not consume any bone broth.

Other: Dr. Kellyann's Bone Broth

Participants will have two bone broth phases, each three weeks in length. Bone broth phases will be separated by a one-week maintenance phase. A one-week maintenance phase will also occur after the second bone broth phase. Each week of a broth phase will consist of five feeding days and five fasting days. On feeding days, participants will consume one packet of bone broth, twice each day, as snacks between meals. On fasting days, participants will consume one packet of bone broth every two hours for a total of seven packets each day.

Outcome Measures

Primary Outcome Measures

The change in weight from baseline at Days 22 and 50 following the bone broth diet. [baseline, day 22, day 50]
The change in body mass index (BMI) from baseline at Days 22 and 50 following the bone broth diet. [baseline, day 22, day 50]

Secondary Outcome Measures

The change in weight from baseline at Day 28, from Day 22 at Day 28, from Day 28 at Day 50, and from Day 50 at Day 56 following the bone broth diet. [baseline, day 22, day 28, day 50, day 56]
The change in body mass index (BMI) from baseline at Day 28, from Day 22 at Day 28, from Day 28 at Day 50, and from Day 50 at Day 56 following the bone broth diet. [baseline, day 22, day 28, day 50, day 56]
The change in android/gynoid fat ratio from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet. [baseline, day 22, day 28, day 50]
The change in android/gynoid fat ratio from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet as assessed by DEXA measurements.
The change in fat mass (percent or grams) from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet. [baseline, day 22, day 28, day 50]
The change in fat mass from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet as assessed by DEXA measurements.
The change in muscle mass (percent or grams) from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet. [baseline, day 22, day 28, day 50]
The change in muscle mass from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet as assessed by DEXA measurements.
The change in waist circumference from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet. [baseline, day 22, day 28, day 50]
The change in sagittal abdominal diameter (SAD) from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet. [baseline, day 22, day 28, day 50]
The change in hip circumference from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet. [baseline, day 22, day 28, day 50]
The change in arm circumference from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet. [baseline, day 22, day 28, day 50]
The change in thigh circumference from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet. [baseline, day 22, day 28, day 50]
The change in waist-to-hip ratio from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet. [baseline, day 22, day 28, day 50]
The change in blood glucose levels from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet. [baseline, day 22, day 28, day 50]
The change in triglyceride levels from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet. [baseline, day 22, day 28, day 50]
The change in total cholesterol levels from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet. [baseline, day 22, day 28, day 50]
The change in high-density lipoprotein cholesterol (HDL-C) levels from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet. [baseline, day 22, day 28, day 50]
The change in non-high-density lipoprotein cholesterol (non-HDL-C) levels from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet. [baseline, day 22, day 28, day 50]
The change in low-density lipoprotein cholesterol (LDL-C) levels from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet. [baseline, day 22, day 28, day 50]
The change in triglyceride to high-density cholesterol ratio from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet. [baseline, day 22, day 28, day 50]
The change in low-density cholesterol to high-density cholesterol ratio from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet. [baseline, day 22, day 28, day 50]
The change in quality of life from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet. [baseline, day 22, day 28, day 50]
The change in quality of life is assessed by the Modified Short Form (SF)-36 Quality of Life Questionnaire from baseline at Days 22, 28, and 50 and from Day 28 at Day 50 following the bone broth diet. The SF-36 measures nine scales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and reported health transition. The scores range from 0 to 100 where higher scores indicate a better state of health.

Other Outcome Measures

The incidence of pre-emergent and post-emergent adverse events (AE). [baseline to day 50]
Blood pressure (BP) at screening, baseline, day 22, day 28, and day 50 following the bone broth diet. [screening, baseline, day 22, day 28, day 50]
Heart rate (HR) at screening, baseline, day 22, day 28, and day 50 following the bone broth diet. [screening, baseline, day 22, day 28, day 50]
Serum aspartate aminotransferase (AST) measurement at screening, day 22, and day 50 following the bone broth diet. [screening, day 22, day 50]
Serum alanine aminotransferase (ALT) measurement at screening, day 22, and day 50 following the bone broth diet. [screening, day 22, day 50]
Serum alkaline phosphatase (ALP) measurement at screening, day 22, and day 50 following the bone broth diet. [screening, day 22, day 50]
Serum total bilirubin measurement at screening, day 22, and day 50 following the bone broth diet. [screening, day 22, day 50]
Creatinine measurement at screening, day 22, and day 50 following the bone broth diet. [screening, day 22, day 50]
Measurement of electrolytes (sodium, potassium, chloride) at screening, day 22, and day 50 following the bone broth diet. [screening, day 22, day 50]
Measurement of uric acid at screening, day 22, and day 50 following the bone broth diet. [screening, day 22, day 50]
Estimated glomerular filtration rate (eGFR) at screening day 22, and day 50 following the bone broth diet. [screening, day 22, day 50]
White blood cell count (WBC) at screening, day 22, and day 50 following the bone broth diet. [screening, day 22, day 50]
White blood cell count (WBC) with differentials at screening, day 22, and day 50 following the bone broth diet. [screening, day 22, day 50]
WBC with differentials (neutrophils, lymphocytes, monocytes, eosinophils, basophils) will be measured in the serum at screening, day 22, and day 50.
Red blood cell count (RBC) at screening, day 22, and day 50 following the bone broth diet. [screening, day 22, day 50]
Hemoglobin at screening, day 22, and day 50 following the bone broth diet. [screening, day 22, day 50]
Hematocrit at screening, day 22, and day 50 following the bone broth diet. [screening, day 22, day 50]
Platelet count at screening, day 22, and day 50 following the bone broth diet. [screening, day 22, day 50]
Immature granulocytes at screening, day 22, and day 50 following the bone broth diet. [screening, day 22, day 50]
Nucleated red blood cells (RBC) at screening, day 22, and day 50 following the bone broth diet. [screening, day 22, day 50]
Red blood cell (RBC) indices at screening, day 22, and day 50 following the bone broth diet. [screening, day 22, day 50]
RBC indices include mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), and red blood cell distribution width (RDW).
Urine color and appearance at screening, day 22, and day 50 following the bone broth diet. [screening, day 22, day 50]
Urinalysis-chemistry for urinary glucose at screening, day 22, and day 50 following the bone broth diet. [screening, day 22, day 50]
Urinalysis-chemistry for urinary ketones at screening, day 22, and day 50 following the bone broth diet. [screening, day 22, day 50]
Urinalysis-chemistry for urinary specific gravity at screening, day 22, and day 50 following the bone broth diet. [screening, day 22, day 50]
Urinalysis-chemistry for blood at screening, day 22, and day 50 following the bone broth diet. [screening, day 22, day 50]
Urinalysis-chemistry for urinary pH at screening, day 22, and day 50 following the bone broth diet. [screening, day 22, day 50]
Urinalysis-chemistry for urinary proteins at screening, day 22, and day 50 following the bone broth diet. [screening, day 22, day 50]
Urinalysis-chemistry for urinary nitrite at screening, day 22, and day 50 following the bone broth diet. [screening, day 22, day 50]
Urinalysis-chemistry for urinary leukocytes at screening, day 22, and day 50 following the bone broth diet. [screening, day 22, day 50]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Males and females between the age of 35-65 years, inclusive, at screening
BMI between 30.0 and 39.9 kg/m2
Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening

Or,

Individuals 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. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:

Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
Double-barrier method
Intrauterine devices
Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
Vasectomy of partner at least 6 months prior to screening
Abstinence and agrees to use contraception if planning on becoming sexually active

Agrees to maintain current lifestyle habits as much as possible throughout the study depending on your ability to maintain the following: medications, supplements, and sleep
Motivated to comply with dietary and fasting guidelines as assessed by the Motivation Questionnaire at screening (see Appendix 16.2)
Self-reported stable body weight for the past three months defined as not having gained or lost more than 5 kg of body weight throughout the three months prior to screening
Willingness and ability to complete questionnaires, records, and diaries associated with the study, adhere to dietary/fasting guidelines, read the Revised Bone Broth Diet book (chapters 1-5), and to complete all clinic visits
Provided voluntary, written, informed consent to participate in the study

Exclusion Criteria:

Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
Allergy, sensitivity, or intolerance to the investigational product's ingredients
Metal implants or other physical characteristics/limitations that may affect DEXA scan results, as assessed by the QI
Participation within the last three months in any weight loss or diet programs from baseline
Current or history of eating disorders, as assessed by the QI
Obesity-induced by metabolic or endocrinologic disorders (ex. acromegaly, hypothalamic obesity), as assessed by the QI
Current or history of significant diseases of the gastrointestinal tract, as assessed by the QI
Gastric bypass surgery or other surgeries to induce weight loss
History of gout and have had a flare up within past 12 months
Chronic inflammatory diseases, as assessed by the QI
Type I or Type II diabetes (HbA1c ≥6.5%)
Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
Current unstable 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 in participants who are symptom free for 6 months
Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
Cancer, except skin basal cell carcinoma 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
Current use of any prescribed or over-the counter medications and/or supplements that may affect body weight or metabolism, as assessed by the QI (See Sections 7.3.1and 7.3.2)
Regular use of tobacco products within 6 months of baseline and during the study period, as assessed by the QI
Alcohol intake average of >2 standard drinks per day. Occasional users must agree to wash out and abstain during the study period, as assessed by the QI
Alcohol or drug abuse within the last 12 months
Use of medical cannabinoid products
Chronic use of cannabinoid products (>2 times/week). Occasional users must agree to wash out and abstain during the study period
Clinically significant abnormal laboratory results at screening, as assessed by the QI
Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the end of study
Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
Individuals who are unable to give informed consent
Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant