KEtogenic Diet and Its Multiple EffectS on Obesity (KEMESO)

August 9, 2025 updated by: Lucio Gnessi, University of Roma La Sapienza

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00161
        • Sapienza University of Rome

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of changes in Perceived Quality of Life with IWQOL-Lite Questionnaires
Time Frame: 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
At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes in Perceived Quality of Life with SF-36 Questionnaires
Time Frame: 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
At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes in Perceived Quality of Life with "EQ-5D" Questionnaires
Time Frame: 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
At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of weight loss
Time Frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Weight loss expressed in Kg
At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes of perceived sleep
Time Frame: 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
At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes of perceived sleepiness
Time Frame: 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
At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes in clock genes expression
Time Frame: At baseline, at 30 days
Evaluation of the expression of the clock genes in blood cells
At baseline, at 30 days
Evaluation of changes in hormonal profile
Time Frame: At baseline, at 30 days
Assessment of hormonal parameters, as cortisol, expressed in ug/dL
At baseline, at 30 days
Evaluation of changes in sexual function in males
Time Frame: 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
At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes in inflammation
Time Frame: 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
At baseline, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes of peripheral blood mononuclear cells
Time Frame: 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
At baseline, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes in sleep parameters (length)
Time Frame: 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
At baseline, at 30 days
Evaluation of changes in hip circumference
Time Frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Assessment of hip circumference, expressed in cm
At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes in waist circumference
Time Frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Assessment of waist circumference, expressed in cm
At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Change in circadian rhythm
Time Frame: At baseline, at 30 days
Evaluation of change in midpoint of sleep, bedtime, sleep onset, rise time and circadian phase, expressed in hours
At baseline, at 30 days
Evaluation of changes in Sexual Function in Females
Time Frame: 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
At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes in sleep efficiency
Time Frame: At baseline, at 30 days
Sleep efficiency expressed as a percentage; measurement with actigraphy
At baseline, at 30 days
Evaluation of changes in number of awakenings
Time Frame: At baseline, at 30 days
Measurement with actigraphy
At baseline, at 30 days
Evaluation of changes in sleep parameters
Time Frame: At baseline, at 30 days
Evaluation of sleep fragmentation index and movement index, with actigraphy
At baseline, at 30 days
Evaluation of changes in metabolic parameters
Time Frame: At baseline, at 30 days
Evaluation of changes in metabolic parameters, as glucose, triglycerides, cholesterol and HDL, expressed in mmol/L
At baseline, at 30 days
Evaluation of changes in BMI
Time Frame: 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
At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Evaluation of height
Time Frame: At baseline
Assessment of height, expressed in cm
At baseline
Evaluation of changes in whole blood cells gene expression
Time Frame: At baseline, at 30 days
Evaluation of the changes in the expression of blood cells genes, as metabolic, inflammatory and immunological genes, with RNA-seq in whole blood cells
At baseline, at 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2022

Primary Completion (Actual)

May 6, 2022

Study Completion (Actual)

June 23, 2022

Study Registration Dates

First Submitted

April 25, 2023

First Submitted That Met QC Criteria

May 31, 2023

First Posted (Actual)

June 12, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2025

Last Update Submitted That Met QC Criteria

August 9, 2025

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEMESO1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Ketogenic diet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe