An interventional study of Ketogenic diet and Balanced diet in Obesity, sponsored by University of Roma La Sapienza. Completed at 1 site in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-08-14.
Sponsored by University of Roma La Sapienza · Not applicable, Interventional, and Treatment
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 24 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →University of Roma La Sapienza is the lead sponsor of 388 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ketogenic diet for a month, or a longer period if clinically necessary
Other: Ketogenic diet
Balanced diet for a month, or a longer period if clinically necessary
Other: Balanced diet
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.
Evaluation of changes in Perceived Quality of Life with IWQOL-Lite Questionnaires
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
Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes in Perceived Quality of Life with SF-36 Questionnaires
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
Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes in Perceived Quality of Life with "EQ-5D" Questionnaires
Assessment with the questionnaires "EQ-5D"; scale of every item from 1 to 5; the higher the score, the worse the perceived problem
Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Evaluation of weight loss
Weight loss expressed in Kg
Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes of perceived sleep
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
Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes of perceived sleepiness
Assessment with the questionnaires Epworth Sleepiness Scale (ESS); score on a scale from 0 to 24; the higher the score, the higher the sleepiness
Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes in clock genes expression
Evaluation of the expression of the clock genes in blood cells
Time frame: At baseline, at 30 days
Evaluation of changes in hormonal profile
Assessment of hormonal parameters, as cortisol, expressed in ug/dL
Time frame: At baseline, at 30 days
Evaluation of changes in sexual function in males
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
Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes in inflammation
Measurements of circulating cytokines, as interleukin 2 and interleukin 10, expressed in ng/mL
Time frame: At baseline, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes of peripheral blood mononuclear cells
Number of cells of peripheral blood mononuclear cell subpopulations, expressed in number/mm3
Time frame: At baseline, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes in sleep parameters (length)
Assessment with actigraphy of latency, total minutes in bed, total sleep time, wake after sleep onset, average awakening length, expressed in minutes
Time frame: At baseline, at 30 days
Evaluation of changes in hip circumference
Assessment of hip circumference, expressed in cm
Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes in waist circumference
Assessment of waist circumference, expressed in cm
Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Change in circadian rhythm
Evaluation of change in midpoint of sleep, bedtime, sleep onset, rise time and circadian phase, expressed in hours
Time frame: At baseline, at 30 days
Evaluation of changes in Sexual Function in Females
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
Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Evaluation of changes in sleep efficiency
Sleep efficiency expressed as a percentage; measurement with actigraphy
Time frame: At baseline, at 30 days
Evaluation of changes in number of awakenings
Measurement with actigraphy
Time frame: At baseline, at 30 days
Evaluation of changes in sleep parameters
Evaluation of sleep fragmentation index and movement index, with actigraphy
Time frame: At baseline, at 30 days
Evaluation of changes in metabolic parameters
Evaluation of changes in metabolic parameters, as glucose, triglycerides, cholesterol and HDL, expressed in mmol/L
Time frame: At baseline, at 30 days
Evaluation of changes in BMI
Weight and height will be combined to report BMI in kg/m\^2
Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Evaluation of height
Assessment of height, expressed in cm
Time frame: At baseline
Evaluation of changes in whole blood cells gene expression
Evaluation of the changes in the expression of blood cells genes, as metabolic, inflammatory and immunological genes, with RNA-seq in whole blood cells
Time frame: At baseline, at 30 days
Plan to share: No
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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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University of Roma La Sapienza