]>
IRCT20220406054437N1 IRCT 2022-06-01 Shahid Beheshti University of Medical Sciences effect of probiotic on food addiction and weight regain Effects of probiotic supplementation with weight reducing plan on anthropometric measures, body composition, eating behavior, and related hormone levels in patients with food addiction and weight regain after bariatric surgery: A randomized clinical trial 2022-05-15 anticipated 50 Complete https://irct.ir/trial/62885 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is a Triple-blind Randomized Controlled Clinical Trial. A simple method has been used for randomization. Randomization unit is Individual. Excel software has been used for randomization.Using unique codes as ID numbers, using random numbers generated by the software, participants were randomly assigned to the same volume in the intervention and placebo groups. (Description of randomization by Excel software: In the first step, we generated 50 random numbers according to the sample size, in the next step, we obtained the rank of these numbers obtained in the first step, in the third step, we divided these numbers by 25, in the fourth step, the numbers that fell between zero and one were in the intervention group and the rest in the placebo group) The central service method was used for allocation concealment and someone outside our study performed allocation concealment and labeling of supplements, Blinding description: Study participants, main study researchers, intervention and treatment partners, data collectors, and data analyzers were blinded in this study, and someone outside the study was used for randomization and labeling of probiotic and placebo supplements. N/A Food addiction, Weight regain after bariatric surgery. Intervention 1: Intervention group: Intervention group: Multi-strain probiotics were used. Each probiotic capsule contains Lactobacillus acidophilus (1.8 × 109 CFU / capsule), Bifidobacterium bifidum (1.8 × 109 CFU / capsule), Bifidobacterium lactis (1.8 × 109 CFU / capsule), Bifidobacterium longul / C, 1.8 (1 × 109 CFU / capsule), Lactobacillus reuteri (1 × 109 CFU / capsule), magnesium stearate and maltodextrin. participants take 2 capsules daily (after breakfast and after lunch) for 12 weeks. Prepared by Tach Gene Zist Company. All individuals are given a hypocaloric (-300 to 500 kcal/day), high-protein (25% of energy) diet based on basal metabolism rate (using indirect calorimetry) and level of physical activity (using metabolic equivalents task: MET). For all individuals, ten sessions (Once a week individually) of congenital behavioral therapy (CBT) intervention will be performed online based on the Michael Frey protocol. Intervention 2: Control group: participants in the control group take two placebo capsules (after breakfast and lunch) daily for 12 weeks, containing 300 mg of starch. The capsules are completely similar in shape, size and color to the intervention capsules and are prepared by Tach Gene Zist Company. All individuals are given a hypocaloric (-300 to 500 kcal/day), high-protein (25% of energy) diet based on basal metabolism rate (using indirect calorimetry) and level of physical activity (using metabolic equivalents task: MET). For all individuals, ten sessions (Once a week individually) of congenital behavioral therapy (CBT) intervention will be performed online based on the Michael Frey protocol. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentifiable individuals When: Access period starts 6 months after the results are published To whom: Academic researchers and people working in industry Conditions: In order to do research work or make medical products Where to obtain: Send email to the Atoosa Saidpour ( Atoosa Saidpour@gmail.com) How to obtain: After sending the necessary documents to confirm the research or industrial project Comments:
public Atoosa Saidpour
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2207 7425 Atoosa.Saidpour@gmail.com Shahid Beheshti University of Medical Sciences scientific Atoosa Saidpour
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2207 7425 Atoosa.Saidpour@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Willingness to participate in the study Being in the age range of 18-50 years At least 18 months have passed since the date of bariatric surgery and have a weight regain of at least 10% of the minimum weight gained Confirmation of food addiction after obtaining the necessary points from the relevant questionnaire (YFAS) 18 years 50 years Both Reluctance to cooperate in the study Pregnancy, breastfeeding professional athlete Use of any antibiotics in the last three weeks Use any probiotic product or protein supplement in a recent month Liver disease (other than fatty liver), kidney, cancer and thyroid disease Use of weight loss and appetite suppressants Treatment - Other Placebo Intervention group: Intervention group: Multi-strain probiotics were used. Each probiotic capsule contains Lactobacillus acidophilus (1.8 × 109 CFU / capsule), Bifidobacterium bifidum (1.8 × 109 CFU / capsule), Bifidobacterium lactis (1.8 × 109 CFU / capsule), Bifidobacterium longul / C, 1.8 (1 × 109 CFU / capsule), Lactobacillus reuteri (1 × 109 CFU / capsule), magnesium stearate and maltodextrin. participants take 2 capsules daily (after breakfast and after lunch) for 12 weeks. Prepared by Tach Gene Zist Company. All individuals are given a hypocaloric (-300 to 500 kcal/day), high-protein (25% of energy) diet based on basal metabolism rate (using indirect calorimetry) and level of physical activity (using metabolic equivalents task: MET). For all individuals, ten sessions (Once a week individually) of congenital behavioral therapy (CBT) intervention will be performed online based on the Michael Frey protocol. Control group: participants in the control group take two placebo capsules (after breakfast and lunch) daily for 12 weeks, containing 300 mg of starch. The capsules are completely similar in shape, size and color to the intervention capsules and are prepared by Tach Gene Zist Company. All individuals are given a hypocaloric (-300 to 500 kcal/day), high-protein (25% of energy) diet based on basal metabolism rate (using indirect calorimetry) and level of physical activity (using metabolic equivalents task: MET). For all individuals, ten sessions (Once a week individually) of congenital behavioral therapy (CBT) intervention will be performed online based on the Michael Frey protocol. Weight changes. Timepoint: At the beginning of the study and three months after the intervention. Method of measurement: Digital scale with an accuracy of 0.1 kg. Food addiction. Timepoint: At the beginning of the study and three months after the intervention. Method of measurement: Yale Food Addiction Scale; YFAS. Levels of the hormones leptin, serotonin and oxytocin. Timepoint: At the beginning of the study and three months after the intervention. Method of measurement: By ELISA method. Shahid Beheshti University of Medical Sciences Approved 2022-02-19 Ethics committee of Shahid Beheshti University of Medical Science Next to Ayatollah Taleghani Hospital, Arabi Street, Yemen Street, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)