KEMESO: KEtogenic Diet and Its Multiple EffectS on Obesity

Sponsor

University of Roma La Sapienza (Other)

Overall Status

Completed

CT.gov ID

NCT05898204

Collaborator

(none)

Enrollment

Location

Arms

4.6

Actual Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The prevalence of obesity and metabolic disturbances is worryingly increasing worldwide, therefore the study of their pathophysiology is extremely important to find new strategies for their treatment. Obesity has a strong impact not only on the metabolism of the patients, but also may impact hormonal, inflammatory and immune profile, and profoundly influence the daily life of the patients. Weight loss may determine an amelioration of these parameters, but the impact of the diet composition aimed to weight loss on them has not been profoundly studied yet.

The aim of our research project is to study the effects of a ketogenic diet in comparison with an isocaloric balanced diet on weight loss and anthropometric parameters, quality of life, hormone profile, sleep, sexual function, circadian rhythm, inflammatory and immunological parameters in obese patients.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Other: Ketogenic diet Other: Balanced diet	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients are sequentially allocated to one of the 2 arms of intervention: the ketogenic diet arm or the balanced diet arm.Patients are sequentially allocated to one of the 2 arms of intervention: the ketogenic diet arm or the balanced diet arm.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison of the Effects of a Ketogenic Diet and an Isocaloric Balanced Diet in Obese Patients: a Randomized Clinical Trial

Actual Study Start Date :

Feb 3, 2022

Actual Primary Completion Date :

May 6, 2022

Actual Study Completion Date :

Jun 23, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ketogenic diet arm Ketogenic diet for a month, or a longer period if clinically necessary	Other: Ketogenic diet Prescription of a ketogenic diet, 1200 Kcal/die. Patients are encouraged to walk 30 minutes every day.
Active Comparator: Balanced diet arm Balanced diet for a month, or a longer period if clinically necessary	Other: Balanced diet Prescription of a balanced diet, 1200 Kcal/die. Patients are encouraged to walk 30 minutes every day.

Arm

Intervention/Treatment

Experimental: Ketogenic diet arm

Ketogenic diet for a month, or a longer period if clinically necessary

Other: Ketogenic diet

Prescription of a ketogenic diet, 1200 Kcal/die. Patients are encouraged to walk 30 minutes every day.

Active Comparator: Balanced diet arm

Balanced diet for a month, or a longer period if clinically necessary

Other: Balanced diet

Prescription of a balanced diet, 1200 Kcal/die. Patients are encouraged to walk 30 minutes every day.

Outcome Measures

Primary Outcome Measures

Evaluation of changes in Perceived Quality of Life with IWQOL-Lite Questionnaires [At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet]
Assessment with the questionnaires Impact of weight/Quality of Life-Lite (IWQOL-Lite); global scale from 0 to 100; the higher the score, the better the quality of life
Evaluation of changes in Perceived Quality of Life with SF-36 Questionnaires [At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet]
Assessment with the questionnaires Short Form Health Survey 36 (SF-36); scale of every item from 0 to 100; the higher the score, the better the quality of life
Evaluation of changes in Perceived Quality of Life with "EQ-5D" Questionnaires [At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet]
Assessment with the questionnaires "EQ-5D"; scale of every item from 1 to 5; the higher the score, the worse the perceived problem

Secondary Outcome Measures

Evaluation of weight loss [At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet]
Weight loss expressed in Kg
Evaluation of changes of perceived sleep [At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet]
Assessment with the questionnaires Pittsburgh Sleep Quality Index; global score on a scale from 0 to 21; the higher the score, the worse the sleep quality
Evaluation of changes of perceived sleepiness [At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet]
Assessment with the questionnaires Epworth Sleepiness Scale (ESS); score on a scale from 0 to 24; the higher the score, the higher the sleepiness
Evaluation of changes in clock genes expression [At baseline, at 30 days]
Evaluation of the expression of the clock genes in blood cells
Evaluation of changes in hormonal profile [At baseline, at 30 days]
Assessment of hormonal parameters, as cortisol, expressed in ug/dL
Evaluation of changes in sexual function in males [At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet]
Assessed with the questionnaires International Index of Erectile Function (IIEF-5); scale from 5 to 25; the higher the score, the better the erectile function
Evaluation of changes in inflammation [At baseline, at 30 days, at 60 days if the patient continued the diet]
Measurements of circulating cytokines, as interleukin 2 and interleukin 10, expressed in ng/mL
Evaluation of changes of peripheral blood mononuclear cells [At baseline, at 30 days, at 60 days if the patient continued the diet]
Number of cells of peripheral blood mononuclear cell subpopulations, expressed in number/mm3
Evaluation of changes in sleep parameters (length) [At baseline, at 30 days]
Assessment with actigraphy of latency, total minutes in bed, total sleep time, wake after sleep onset, average awakening length, expressed in minutes
Evaluation of changes in hip circumference [At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet]
Assessment of hip circumference, expressed in cm
Evaluation of changes in waist circumference [At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet]
Assessment of waist circumference, expressed in cm
Change in circadian rhythm [At baseline, at 30 days]
Evaluation of change in midpoint of sleep, bedtime, sleep onset, rise time and circadian phase, expressed in hours
Evaluation of changes in Sexual Function in Females [At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet]
Assessed with the questionnaire Female Sexual Function Index (FSFI); scale of every item from 1 to 5; the higher score, the better the sexual function
Evaluation of changes in sleep efficiency [At baseline, at 30 days]
Sleep efficiency expressed as a percentage; measurement with actigraphy
Evaluation of changes in number of awakenings [At baseline, at 30 days]
Measurement with actigraphy
Evaluation of changes in sleep parameters [At baseline, at 30 days]
Evaluation of sleep fragmentation index and movement index, with actigraphy
Evaluation of changes in metabolic parameters [At baseline, at 30 days]
Evaluation of changes in metabolic parameters, as glucose, triglycerides, cholesterol and HDL, expressed in mmol/L
Evaluation of changes in BMI [At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet]
Weight and height will be combined to report BMI in kg/m^2
Evaluation of height [At baseline]
Assessment of height, expressed in cm

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age between 18 and 65 years
BMI≥ 30 Kg/m2

Exclusion Criteria:

Type 1 diabetes mellitus and latent autoimmune diabetes in adults
β-cell failure in type 2 diabetes mellitus
Use of sodium/glucose cotransporter 2 (SGLT2) inhibitors
Pregnancy and breastfeeding
Kidney failure and moderate-to-severe chronic kidney disease
Liver failure
Heart failure (NYHA III-IV)
Respiratory failure
Unstable angina, stroke or myocardial infarction in the last 12 months
Cardiac arrhythmias
Eating disorders and other severe mental illnesses, alcohol and substance abuse
Active/severe infections
Planned elective surgery or invasive procedures
Rare disorders: porphyria, carnitine deficiency, carnitine palmitoyltransferase deficiency, carnitine-acylcarnitine translocase deficiency, mitochondrial fatty acid β-oxidation disorders, pyruvate carboxylase deficiency