The effect of a low-calorie, high-protein diet on anthropometric measurements, body composition, and sleep quantity and quality in obese individuals; a randomized clinical trial

Determining the effects of low-calorie, high-protein diet on anthropometric measurements, body composition, amount and quality of sleep in obese people.

A clinical trial with a control group, with a randomized parallel group, 30 people are given a diet in each group. The SEALDEVENLOPE standard website was used for randomization and blocking.

The present study is an open-label randomized clinical trial (RCT) with the target population of adults and diagnosed with obesity (BMI>29.9, confirmed by a nutritionist) of the city. Mashhad, who went to the nutrition clinic of Qaim Hospital to receive a diet and the presence of low sleep quality was confirmed by a sleep medicine specialist.

Study inclusion Body mass index higher than 29.9 kg/m2 Disturbed sleep quality by PSQI questionnaire with a higher score equal to 6 and stop bang higher equal to 3 Non-entry Having underlying diseases such as: heart diseases, low blood pressure, diabetes, cancer, autoimmune diseases Overweight people

In the intervention group, caloric restriction was applied and the protein percentage was increased to achieve the mentioned goals, and to obtain 60% of the required proteins, HBV high protein and 40% of vegetable proteins will be used.

Based on the studies, we know that weight loss improves the quality of sleep and improves the indices related to it, but the lack of a study that has the right sample size, the right distribution of the sample in two groups, the minimal effect of confounders to investigate the effect The ratio of protein in the diet is important, especially with accurate tools for its evaluation, such as polysomnography, especially in the environment of Iranian society.

After obtaining informed consent and checking the enter criteria, we will divided study population, randomly, by using the block classification method, based on the body mass index (30-35 and more than 35), age (18 up to 45 years and more than 45 years), and gender (male and female) into two groups: intervention and control groups through the closed-door envelope method. All the steps of randomization and blocking will be done by the dedicated standard website of SEALDEVENLOPE by one of the collaborators of the project who is not involved in the implementation process of the clinical phase of the study. Through the analytic calculation, the target sample size for each group should be 30 people. 5 individuals whose poor quality of sleep has been determined by a sleep medicine specialist and also, have the indication and compliance for further investigation of sleep apnea through polysomnography, will be randomly selected. Those people, should sleep two nights (8 hours on each night) on days 0 and 90 of study, in Imam Reza Hospital in the department of sleep disorders for further investigations.

Still undecided - no release schedule yet

Still undecided - no release schedule yet

Still undecided - no release schedule yet

Still undecided - no release schedule yet

Still undecided - no release schedule yet

Still undecided - no release schedule yet