KEtogenic Diet and Its Multiple EffectS on Obesity
- Conditions
- Obesity
- Interventions
- Other: Ketogenic dietOther: Balanced diet
- Registration Number
- NCT05898204
- Lead Sponsor
- University of Roma La Sapienza
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- Age between 18 and 65 years
- BMI≥ 30 Kg/m2
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ketogenic diet arm Ketogenic diet Ketogenic diet for a month, or a longer period if clinically necessary Balanced diet arm Balanced diet Balanced diet for a month, or a longer period if clinically necessary
- Primary Outcome Measures
Name Time Method Evaluation of changes in Perceived Quality of Life with SF-36 Questionnaires 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 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 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 Outcome Measures
Name Time Method Evaluation of changes in number of awakenings At baseline, at 30 days Measurement with actigraphy
Evaluation of weight loss At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet Weight loss expressed in Kg
Evaluation of changes in hormonal profile At baseline, at 30 days Assessment of hormonal parameters, as cortisol, expressed in ug/dL
Evaluation of changes in hip circumference At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet Assessment of hip circumference, expressed in cm
Evaluation of changes in waist circumference At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet Assessment of waist circumference, expressed in cm
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 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 height At baseline Assessment of height, expressed in cm
Evaluation of changes of peripheral blood mononuclear cells At baseline, at 30 days, at 60 days if the patient continued the diet Number of cells of peripheral blood mononuclear cell subpopulations, expressed in number/mm3
Change in circadian rhythm At baseline, at 30 days Evaluation of change in midpoint of sleep, bedtime, sleep onset, rise time and circadian phase, expressed in hours
Evaluation of changes in sleep efficiency At baseline, at 30 days Sleep efficiency expressed as a percentage; measurement with actigraphy
Evaluation of changes in clock genes expression At baseline, at 30 days Evaluation of the expression of the clock genes in blood cells
Evaluation of changes in sleep parameters At baseline, at 30 days Evaluation of sleep fragmentation index and movement index, with actigraphy
Evaluation of changes of perceived sleep At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet 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
Evaluation of changes of perceived sleepiness At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet Assessment with the questionnaires Epworth Sleepiness Scale (ESS); score on a scale from 0 to 24; the higher the score, the higher the sleepiness
Evaluation of changes in metabolic parameters At baseline, at 30 days Evaluation of changes in metabolic parameters, as glucose, triglycerides, cholesterol and HDL, expressed in mmol/L
Evaluation of changes in BMI At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet Weight and height will be combined to report BMI in kg/m\^2
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 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
Evaluation of changes in inflammation At baseline, at 30 days, at 60 days if the patient continued the diet Measurements of circulating cytokines, as interleukin 2 and interleukin 10, expressed in ng/mL
Evaluation of changes in sleep parameters (length) At baseline, at 30 days Assessment with actigraphy of latency, total minutes in bed, total sleep time, wake after sleep onset, average awakening length, expressed in minutes
Trial Locations
- Locations (1)
Sapienza University of Rome
🇮🇹Roma, Italy