KEtogenic Diet and Its Multiple EffectS on Obesity

Obesity Clinical Trial

— KEMESO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05898204
• Other study ID #: KEMESO1
• Status: Completed
• Phase: N/A
• Start date: February 3, 2022
• Est. completion date: June 23, 2022

Study information

• Verified date: May 2023
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 23, 2022
• Est. primary completion date: May 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age between 18 and 65 years

• BMI= 30 Kg/m2

Exclusion Criteria:

• Type 1 diabetes mellitus and latent autoimmune diabetes in adults

• ß-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 ß-oxidation disorders, pyruvate carboxylase deficiency

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Ketogenic diet
Prescription of a ketogenic diet, 1200 Kcal/die. Patients are encouraged to walk 30 minutes every day.
• Balanced diet
Prescription of a balanced diet, 1200 Kcal/die. Patients are encouraged to walk 30 minutes every day.

Locations

Country	Name	City	State
Italy	Sapienza University of Rome	Roma

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of changes in Perceived Quality of Life with IWQOL-Lite Questionnaires	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	At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Primary	Evaluation of changes in Perceived Quality of Life with SF-36 Questionnaires	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	At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Primary	Evaluation of changes in Perceived Quality of Life with "EQ-5D" Questionnaires	Assessment with the questionnaires "EQ-5D"; scale of every item from 1 to 5; the higher the score, the worse the perceived problem	At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Secondary	Evaluation of weight loss	Weight loss expressed in Kg	At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Secondary	Evaluation of changes of perceived sleep	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	At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Secondary	Evaluation of changes of perceived sleepiness	Assessment with the questionnaires Epworth Sleepiness Scale (ESS); score on a scale from 0 to 24; the higher the score, the higher the sleepiness	At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Secondary	Evaluation of changes in clock genes expression	Evaluation of the expression of the clock genes in blood cells	At baseline, at 30 days
Secondary	Evaluation of changes in hormonal profile	Assessment of hormonal parameters, as cortisol, expressed in ug/dL	At baseline, at 30 days
Secondary	Evaluation of changes in sexual function in males	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	At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Secondary	Evaluation of changes in inflammation	Measurements of circulating cytokines, as interleukin 2 and interleukin 10, expressed in ng/mL	At baseline, at 30 days, at 60 days if the patient continued the diet
Secondary	Evaluation of changes of peripheral blood mononuclear cells	Number of cells of peripheral blood mononuclear cell subpopulations, expressed in number/mm3	At baseline, at 30 days, at 60 days if the patient continued the diet
Secondary	Evaluation of changes in sleep parameters (length)	Assessment with actigraphy of latency, total minutes in bed, total sleep time, wake after sleep onset, average awakening length, expressed in minutes	At baseline, at 30 days
Secondary	Evaluation of changes in hip circumference	Assessment of hip circumference, expressed in cm	At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Secondary	Evaluation of changes in waist circumference	Assessment of waist circumference, expressed in cm	At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Secondary	Change in circadian rhythm	Evaluation of change in midpoint of sleep, bedtime, sleep onset, rise time and circadian phase, expressed in hours	At baseline, at 30 days
Secondary	Evaluation of changes in Sexual Function in Females	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	At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Secondary	Evaluation of changes in sleep efficiency	Sleep efficiency expressed as a percentage; measurement with actigraphy	At baseline, at 30 days
Secondary	Evaluation of changes in number of awakenings	Measurement with actigraphy	At baseline, at 30 days
Secondary	Evaluation of changes in sleep parameters	Evaluation of sleep fragmentation index and movement index, with actigraphy	At baseline, at 30 days
Secondary	Evaluation of changes in metabolic parameters	Evaluation of changes in metabolic parameters, as glucose, triglycerides, cholesterol and HDL, expressed in mmol/L	At baseline, at 30 days
Secondary	Evaluation of changes in BMI	Weight and height will be combined to report BMI in kg/m^2	At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Secondary	Evaluation of height	Assessment of height, expressed in cm	At baseline