Clinical trial NCT05898204: KEtogenic Diet and Its Multiple EffectS on Obesity
Official title: Comparison of the Effects of a Ketogenic Diet and an Isocaloric Balanced Diet in Obese Patients: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
metabolism
circadian rhythm
sleep
quality of life
balanced diet
ketogenic diet
immune profile
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are sequentially allocated to one of the 2 arms of intervention: the ketogenic diet arm or the balanced diet arm.
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: Evaluation of changes in Perceived Quality of Life with IWQOL-Lite Questionnaires
timeFrame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
measure: Evaluation of changes in Perceived Quality of Life with SF-36 Questionnaires
timeFrame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
measure: Evaluation of changes in Perceived Quality of Life with "EQ-5D" Questionnaires
timeFrame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
Secondary outcomes:
measure: Evaluation of weight loss
timeFrame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
measure: Evaluation of changes of perceived sleep
timeFrame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
measure: Evaluation of changes of perceived sleepiness
timeFrame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
measure: Evaluation of changes in clock genes expression
timeFrame: At baseline, at 30 days
measure: Evaluation of changes in hormonal profile
timeFrame: At baseline, at 30 days
measure: Evaluation of changes in sexual function in males
timeFrame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
measure: Evaluation of changes in inflammation
timeFrame: At baseline, at 30 days, at 60 days if the patient continued the diet
measure: Evaluation of changes of peripheral blood mononuclear cells
timeFrame: At baseline, at 30 days, at 60 days if the patient continued the diet
measure: Evaluation of changes in sleep parameters (length)
timeFrame: At baseline, at 30 days
measure: Evaluation of changes in hip circumference
timeFrame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
measure: Evaluation of changes in waist circumference
timeFrame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
measure: Change in circadian rhythm
timeFrame: At baseline, at 30 days
measure: Evaluation of changes in Sexual Function in Females
timeFrame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
measure: Evaluation of changes in sleep efficiency
timeFrame: At baseline, at 30 days
measure: Evaluation of changes in number of awakenings
timeFrame: At baseline, at 30 days
measure: Evaluation of changes in sleep parameters
timeFrame: At baseline, at 30 days
measure: Evaluation of changes in metabolic parameters
timeFrame: At baseline, at 30 days
measure: Evaluation of changes in BMI
timeFrame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet
measure: Evaluation of height
timeFrame: At baseline
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Sapienza University of Rome
Study officials:
References: