Comparison of the Effects of a Ketogenic Diet and an Isocaloric Balanced Diet in Obese Patients: a Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- University of Roma La Sapienza
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Evaluation of changes in Perceived Quality of Life with SF-36 Questionnaires
- Status
- Completed
- Last Updated
- 8 months ago
Overview
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.
Investigators
Lucio Gnessi
Full Professor
University of Roma La Sapienza
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
Outcomes
Primary Outcomes
Evaluation of changes in Perceived Quality of Life with SF-36 Questionnaires
Time Frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
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
Evaluation of changes in Perceived Quality of Life with IWQOL-Lite Questionnaires
Time Frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
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
Evaluation of changes in Perceived Quality of Life with "EQ-5D" Questionnaires
Time Frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Assessment with the questionnaires "EQ-5D"; scale of every item from 1 to 5; the higher the score, the worse the perceived problem
Secondary Outcomes
- 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 peripheral blood mononuclear cells(At baseline, 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 sleep efficiency(At baseline, at 30 days)
- Evaluation of height(At baseline)
- Evaluation of changes in whole blood cells gene expression(At baseline, at 30 days)
- Evaluation of changes in clock genes expression(At baseline, at 30 days)
- Evaluation of changes in sexual function in males(At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet)
- Evaluation of changes in number of awakenings(At baseline, at 30 days)
- Evaluation of changes in hormonal profile(At baseline, at 30 days)
- Evaluation of changes in inflammation(At baseline, at 30 days, at 60 days if the patient continued the diet)
- Evaluation of changes in sleep parameters (length)(At baseline, at 30 days)
- Evaluation of changes in hip circumference(At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet)
- Evaluation of changes in waist circumference(At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet)
- Evaluation of changes in sleep parameters(At baseline, at 30 days)
- Change in circadian rhythm(At baseline, at 30 days)
- Evaluation of changes in Sexual Function in Females(At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet)
- Evaluation of changes in metabolic parameters(At baseline, at 30 days)
- Evaluation of changes in BMI(At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet)