KEtogenic Diet and Its Multiple EffectS on Obesity

NCT05898204 | Completed

• 1 other identifier: KEMESO1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

obesity; metabolism; circadian rhythm; sleep; quality of life; balanced diet; ketogenic diet; immune profile

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (20)

• Evaluation of weight loss

  At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet

• Evaluation of changes of perceived sleep

  At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet

• Evaluation of changes of perceived 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

  At baseline, at 30 days

• Evaluation of changes in hormonal profile

  At baseline, at 30 days

Study Arms (2)

Ketogenic diet arm

EXPERIMENTAL

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

Other: Ketogenic diet

Balanced diet arm

ACTIVE COMPARATOR

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

Other: Balanced diet

Interventions

Ketogenic diet OTHER

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

Ketogenic diet arm

Balanced diet OTHER

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

Balanced diet arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Sapienza University of Rome

Roma, Roma, 00161, Italy

Location

MeSH Terms

Conditions

Obesity

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

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

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: June 12, 2023
• Study Start: February 3, 2022
• Primary Completion: May 6, 2022
• Study Completion: June 23, 2022
• Last Updated: August 14, 2025

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)