KEtogenic Diet and Its Multiple EffectS on Obesity (KEMESO)

University of Roma La Sapienza

Status: Completed

Conditions: Obesity

Treatments: Other: Ketogenic diet; Other: Balanced diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05898204

KEMESO1

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Ketogenic diet arm

Experimental group

Description:

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

Treatment:

Other: Ketogenic diet

Balanced diet arm

Active Comparator group

Description:

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

Treatment:

Other: Balanced diet