KEtogenic Diet and Its Multiple EffectS on Obesity

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.

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