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IRCT20221101056371N1 IRCT 2022-11-08 Tabriz University of Medical Sciences effect of high protein diet on sleep quality in obese people 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 2022-11-22 anticipated 60 Complete https://irct.ir/trial/66613 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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. N/A Obesity- Sleep disorders. Intervention 1: Intervention group: People in both control and intervention groups are given a diet with required calories and with a calorie deficit equivalent to 750 kcal. People in both the control and intervention groups are given a diet with required calories and with a calorie deficit equal to 750 kcal, with the difference that the diet in the intervention group is a diet with an increased protein ratio (30% protein). The intervention is limited Applied calories and increased protein percentage to achieve the mentioned goals and to obtain 60% of the needed proteins, HBV high protein and 40% of vegetable proteins will be used. The composition of the participants' diet, including micronutrients and macronutrients, is confirmed by N4 software in order to match the designed diet with food intake standards. Intervention 2: Control group: People in both control and intervention groups are given a diet with required calories and with a calorie deficit equivalent to 750 kcal. Diet in the control group is prescribed with a standard protein percentage based on table food (12% protein). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Still undecided - no release schedule yet
public Fatemeh Sadat Hashemi Javaheri
No. 105.2, Jalal Al Ahmad 26, Vakil Abad blvd, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9165617178 +98 51 3608 2257 fatemeh.hjavaheri76@gmail.com Tabriz University of Medical Sciences scientific Fatemeh Sadat Hashemi Javaheri
No. 105.2, Jalal Al Ahmad 26, Vakil Abad blvd, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9165617178 +98 51 3608 2257 fatemeh.hjavaheri76@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Adults 18-65 years old At least in the last 3 months, they have not been subjected to any nutrition and diet intervention. Do not have unwanted weight loss. Do not be treated with any nutritional supplements or herbal medicine. Disturbed sleep quality by PSQI questionnaire with a higher score equal to 6 and stop bang higher equal to 3 Body mass index (BMI) more than 29.9 kg/m2 18 years 65 years Both Having underlying diseases such as: heart diseases, low blood pressure, diabetes, cancer, autoimmune diseases Overweight people pregnant women Lactating women Having psychological diseases or disorders in the mental health screening questionnaire E66.0 Obesity due to excess calories Treatment - Other Treatment - Other Intervention group: People in both control and intervention groups are given a diet with required calories and with a calorie deficit equivalent to 750 kcal. People in both the control and intervention groups are given a diet with required calories and with a calorie deficit equal to 750 kcal, with the difference that the diet in the intervention group is a diet with an increased protein ratio (30% protein). The intervention is limited Applied calories and increased protein percentage to achieve the mentioned goals and to obtain 60% of the needed proteins, HBV high protein and 40% of vegetable proteins will be used. The composition of the participants' diet, including micronutrients and macronutrients, is confirmed by N4 software in order to match the designed diet with food intake standards. Control group: People in both control and intervention groups are given a diet with required calories and with a calorie deficit equivalent to 750 kcal. Diet in the control group is prescribed with a standard protein percentage based on table food (12% protein). Comparing the effects of diets on sleep quality in obese people, the primary outcome can be "quality score and sleep apnea in Saint Petersburg and Stop Bang questionnaires and polysomnography test report". Timepoint: Investigating the quality of sleep before the intervention and 90 days after the intervention. Method of measurement: St.Petersburg questionnaire, stop bang and polysomnography test. Comparing the effects of diets on anthropometric measurements, body composition. Timepoint: Body composition measurement (before the intervention), 15, 30, 60 and 90 days after following the diet. Method of measurement: Body analysis device Tanita MC780. Tabriz University of Medical Sciences Approved 2022-10-31 Ethics committee of Tabriz University of Medical Sciences No. 105.2, Jalal Al Ahmad 26, Vakil Abad blvd, Mashhad, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)