]>
IRCT20180805040703N2 IRCT 2022-05-07 Shahid Beheshti University of Medical Sciences The effect of low carbohydrate diet on food addiction and gut microflora The effect of reduced-carbohydrate diet based on high fiber sources on food addiction and gut microbiota of obese adolescents 2022-04-21 anticipated 70 Complete https://irct.ir/trial/61830 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the block randomization method will be used. 70 participants will be assigned into two groups of diets (A intervention diet and B control diet) using a computer randomization list. This list will be created through the randomization.com website (http://www.randomization.com). Considering 6 blocks and 12 subjects in each block, a list of 72 subjects will be assigned to different groups, which 2 of them will be deleted due to the sample size of 70. Individuals are assigned to two groups according to the order (from the first person number 1 to the last person number 70) who enter the study and according to the compiled randomization list. By researcher number 1, each person's number will be written on the envelope and the group will be placed inside a sealed envelope to ensure that the assigned order is hidden, and then the envelopes will be given to researcher number 2. N/A Condition 1: obesity. Condition 2: food addiction. Condition 3: gut microbiota. Intervention 1: Intervention group: 3 months low calorie diet with reduced carbohydrates based on high fiber sources. Intervention 2: Control group: Standard low calorie diet. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Yasaman Khorshidi
No 7, Hafezi St, Farahzadi Blv, Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 khorshidiyasaman@gmail.com Shahid Beheshti University of Medical Sciences scientific Golaleh Asghari
No 7, Hafezi St, Farahzadi Blv, Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 g_asghari@hotmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Adolescents 12-19 years old Obese, body mass index higher than 2 standard deviations from the average standard set for age and sex by the World Health Organization for children or adolescents between 5-19 years Has at least 3 signs of food addiction questionnaire symptoms and significant clinical disorder or discomfort Willingness to participate in the study 12 years 19 years Both Taking antibiotics for more than 3 days during the previous 3 months Taking medications or supplements such as probiotics or prebiotics that alter the gastrointestinal microbiota for more than 3 days in the past 1 month Participate in other weight loss programs in the previous 3 months and Suffering from any type of metabolic, renal, cardiovascular, thyroid, liver and gastrointestinal diseases Secondary obesity such as Cushing's syndrome, hypothyroidism, hypogonadal or pituitary obesity History of eating disorders Current use of corticosteroids for more than 5 days a month Use of medications to treat psychosis or manic-depressive illness such as lithium, carbamazepine, valproic acid History of surgery in the last 3 months (history of obesity surgery) History of weight fluctuations of more than 5 kg in the last 2 months E66.0 Obesity due to excess calories Treatment - Other Treatment - Other Intervention group: 3 months low calorie diet with reduced carbohydrates based on high fiber sources Control group: Standard low calorie diet Weight. Timepoint: At the beginning and end of the study (3 months after starting the diet). Method of measurement: Digital scales. Body mass index. Timepoint: At the beginning and end of the study (3 months after starting the diet). Method of measurement: calculation. Food Addiction Score. Timepoint: At the beginning and end of the study (3 months after starting the diet). Method of measurement: Yale Food Addiction Scale. Abundance of actionbacteria. Timepoint: At the beginning and end of the study (3 months after starting the diet). Method of measurement: Polymerase chain reaction test. Abundance of firmicutes. Timepoint: At the beginning and end of the study (3 months after starting the diet). Method of measurement: Polymerase chain reaction test. Abundance of bacteroidetes. Timepoint: At the beginning and end of the study (3 months after starting the diet). Method of measurement: Polymerase chain reaction test. Abundance of proteobacteria. Timepoint: At the beginning and end of the study (3 months after starting the diet). Method of measurement: Polymerase chain reaction test. Abundance of verrucomicrobia. Timepoint: At the beginning and end of the study (3 months after starting the diet). Method of measurement: Polymerase chain reaction test. Abundance of bifidobacterium. Timepoint: At the beginning and end of the study (3 months after starting the diet). Method of measurement: Polymerase chain reaction test. Abundance of Escherichia. Timepoint: At the beginning and end of the study (3 months after starting the diet). Method of measurement: Polymerase chain reaction test. Abundance of lactobacillus. Timepoint: At the beginning and end of the study (3 months after starting the diet). Method of measurement: Polymerase chain reaction test. Abundance of bacteroides. Timepoint: At the beginning and end of the study (3 months after starting the diet). Method of measurement: Polymerase chain reaction test. Abundance of prevotella. Timepoint: At the beginning and end of the study (3 months after starting the diet). Method of measurement: Polymerase chain reaction test. Percentage of body fat. Timepoint: At the beginning and end of the study (3 months after starting the diet). Method of measurement: Bioelectrical impedance analysis. Waist circumference. Timepoint: At the beginning and end of the study (3 months after starting the diet). Method of measurement: tape measure. Average of total daily calorie intake. Timepoint: At the beginning of the study, 45 and 90 days after the start of the intervention (diet). Method of measurement: 24-hour food recall questionnaire. Average total daily carbohydrate intake. Timepoint: At the beginning of the study, 45 and 90 days after the start of the intervention (diet). Method of measurement: 24-hour food recall questionnaire. Average total daily protein intake. Timepoint: At the beginning of the study, 45 and 90 days after the start of the intervention (diet). Method of measurement: 24-hour food recall questionnaire. Average total daily fat intake. Timepoint: At the beginning of the study, 45 and 90 days after the start of the intervention (diet). Method of measurement: 24-hour food recall questionnaire. Average total daily fiber intake. Timepoint: At the beginning of the study, 45 and 90 days after the start of the intervention (diet). Method of measurement: 24-hour food recall questionnaire. Average daily intake of saturated fatty acids. Timepoint: At the beginning of the study, 45 and 90 days after the start of the intervention (diet). Method of measurement: 24-hour food recall questionnaire. Average daily intake of unsaturated fatty acids. Timepoint: At the beginning of the study, 45 and 90 days after the start of the intervention (diet). Method of measurement: 24-hour food recall questionnaire. Fasting serum glucose concentration. Timepoint: At the beginning and end of the study (3 months after starting the diet). Method of measurement: Colorimeter/ laboratory kit. Fasting serum insulin concentration. Timepoint: At the beginning and end of the study (3 months after starting the diet). Method of measurement: enzyme-linked immunosorbent assay/laboratory kit. Total serum cholesterol level. Timepoint: At the beginning and end of the study (3 months after starting the diet). Method of measurement: Colorimeter/ laboratory kit. Serum triglyceride level. Timepoint: At the beginning and end of the study (3 months after starting the diet). Method of measurement: Colorimeter/ laboratory kit. Serum Low density lipoprotein level. Timepoint: At the beginning and end of the study (3 months after starting the diet). Method of measurement: calculation. Serum high density lipoprotein level. Timepoint: At the beginning and end of the study (3 months after starting the diet). Method of measurement: Blood biochemical test / colorimetry. Systolic blood pressure. Timepoint: At the beginning and end of the study (3 months after starting the diet). Method of measurement: sphygmomanometer. Diastolic blood pressure. Timepoint: At the beginning and end of the study (3 months after starting the diet). Method of measurement: sphygmomanometer. Shahid Beheshti University of Medical Sciences Approved 2022-03-14 Ethics Committee of National Nutrition & Food Technology Research Institute No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town Tehran Tehran Iran (Islamic Republic of)