KEtogenic Diet and Its Multiple EffectS on Obesity

NCT ID: NCT05898204

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-03
• Study Completion Date: 2022-06-23

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ketogenic diet arm

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

Group Type: EXPERIMENTAL

Ketogenic diet

Intervention Type: OTHER

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

Balanced diet arm

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

Group Type: ACTIVE_COMPARATOR

Balanced diet

Intervention Type: OTHER

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

Interventions

Ketogenic diet

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

Intervention Type: OTHER

Balanced diet

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Lucio Gnessi

Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sapienza University of Rome

Roma, Roma, Italy

Countries

Italy

Other Identifiers

KEMESO1

Identifier Type: -

Identifier Source: org_study_id