KEtogenic Diet and Its Multiple EffectS on Obesity (KEMESO)

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.

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

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

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

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

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

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

Assessment with the questionnaires "EQ-5D"; scale of every item from 1 to 5; the higher the score, the worse the perceived problem

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

Assessment with the questionnaires Epworth Sleepiness Scale (ESS); score on a scale from 0 to 24; the higher the score, the higher the sleepiness

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

Assessment with actigraphy of latency, total minutes in bed, total sleep time, wake after sleep onset, average awakening length, expressed in minutes

Evaluation of change in midpoint of sleep, bedtime, sleep onset, rise time and circadian phase, expressed in hours

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

Evaluation of changes in metabolic parameters, as glucose, triglycerides, cholesterol and HDL, expressed in mmol/L

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