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IRCT20090420001825N3 IRCT 2020-09-07 Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences The effect of probiotic supplement on weight in obese people Effectiveness assessment of a probiotic supplement on weight control in obese adults: a double blind clinical trial 2020-10-06 anticipated 60 Complete https://irct.ir/trial/50719 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization is performed in order to balance the number of samples assigned to each of the study groups. Web randomization (https://www.sealedenvelope.com) is used for this purpose. The number and characteristics of the participants are entered in the desired position and the individuals are randomly assigned to one of the two intervention and placebo groups, Blinding description: In this study, participants, researchers, and clinical caregivers were unaware that each participant in the study was in the main intervention group (receiving a probiotic supplement) or a placebo (without a probiotic). Supplements and placebos are packaged exactly the same and separated by code. Therefore, people cannot identify which group they belong to. N/A obesity. Intervention 1: Intervention group: Receive a weight loss diet and probiotic supplement for 12 weeks, A weight loss diet (500 kcal less than the daily requirement and the composition of the prescribed diet was 55% carbohydrate, 30% fat and 15%protein) is prescribed for the patient and a probiotic supplement manufactured by the TAKGENE pharmaceutical company (Contains Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus casei, Bifidobacterium langum, 10 to 8 or 9 cfu per capsule) twice per day is prescribed for 12 weeks. Intervention 2: Control group: Receive weight loss diet and placebo for 12 weeks, The usual weight loss diet (500 kcal less than the daily requirement and the composition of the prescribed diet was 55% carbohydrate, 30% fat and 15%protein) is prescribed for the patient and the placebo (containing maltodextrine and magnesium stearate) is prescribed in the same size and shape as supplements made by TAKGENE Pharmaceutical Company, twice per day for 12 weeks. 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 اطلاعات بیشتری وجود ندارد
public Hanieh-Sadat Ejtahed
Chamran Highway, Jalal Al-Ahmad Highway, Shariati Hospital, Fifth Floor, Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences, Obesity and Eating Habits Research Center
Tehran Iran (Islamic Republic of) 1411713137 +98 21 8822 0038 haniejtahed@yahoo.com Tehran University of Medical Sciences scientific Shirin Hasani-Ranjbar
Chamran Highway, Jalal Al-Ahmad Highway, Shariati Hospital, Fifth Floor, Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences, Obesity and Eating Habits Research Center
Tehran Iran (Islamic Republic of) 1411713137 +98 21 8822 0038 sh_hasani@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age range: 20 to 55 years Body mass index: 30 to 40 kg/m2 Interest in participating in the project 20 years 55 years Both unwillingness to cooperate pregnancy and lactation smoking cardiovascular disease (history of myocardial infarction and use of digoxin and warfarin) renal disease (creatinine above 2 mg/dL and GFR less than 30 ) Liver disease (liver enzyme levels two and a half times normal) inflammatory bowel disease such as colitis diabetes cancer history of gastrointestinal surgery use of antibiotics during the two months before the start of the study and during the study taking multivitamin supplements during the study common use of probiotics and prebiotics during the month before the start of the study common use Anti-inflammatory drugs during the month before the start of the study use of weight loss drugs in the last 3 months history of special diet for weight loss in the last 3 months history of mental illness E66 Overweight and obesity Treatment - Other Placebo Intervention group: Receive a weight loss diet and probiotic supplement for 12 weeks, A weight loss diet (500 kcal less than the daily requirement and the composition of the prescribed diet was 55% carbohydrate, 30% fat and 15%protein) is prescribed for the patient and a probiotic supplement manufactured by the TAKGENE pharmaceutical company (Contains Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus casei, Bifidobacterium langum, 10 to 8 or 9 cfu per capsule) twice per day is prescribed for 12 weeks. Control group: Receive weight loss diet and placebo for 12 weeks, The usual weight loss diet (500 kcal less than the daily requirement and the composition of the prescribed diet was 55% carbohydrate, 30% fat and 15%protein) is prescribed for the patient and the placebo (containing maltodextrine and magnesium stearate) is prescribed in the same size and shape as supplements made by TAKGENE Pharmaceutical Company, twice per day for 12 weeks. Weight. Timepoint: Beginning and end of the intervention. Method of measurement: Digital scale. Body mass index. Timepoint: Beginning and end of the intervention. Method of measurement: Formula. Waist circumference and hip circumference. Timepoint: Beginning and end of the intervention. Method of measurement: Tape meter. Waist to hip ratio. Timepoint: Beginning and end of the intervention. Method of measurement: Formula. Fasting glucose blood. Timepoint: Beginning and end of the intervention. Method of measurement: Autoanalyzer. Insulin. Timepoint: Beginning and end of the intervention. Method of measurement: Eliza. Total cholesterol. Timepoint: Beginning and end of the intervention. Method of measurement: Spectrophotometry. HDL. Timepoint: Beginning and end of the intervention. Method of measurement: Spectrophotometry. LDL. Timepoint: Beginning and end of the intervention. Method of measurement: Spectrophotometry. TG. Timepoint: Beginning and end of the intervention. Method of measurement: Spectrophotometry. Liver enzymes (ALT and AST). Timepoint: Beginning and end of the intervention. Method of measurement: Colorimetric test. HsCRP. Timepoint: Beginning and end of the intervention. Method of measurement: Eliza. GLP1. Timepoint: Beginning and end of the intervention. Method of measurement: Eliza. Intestinal microbiota. Timepoint: Beginning and end of the intervention. Method of measurement: Real-time polymerase chain reaction. Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences Approved 2019-03-07 Ethics committee of Endocrinology and Metabolism Research Institute afilliated to Tehran University Chamran Highway, Jalal Al-Ahmad Highway, Shariati Hospital, Fifth Floor, Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences, Obesity and Eating Habits Research Center Tehran Tehran Iran (Islamic Republic of)