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IRCT20140804018677N28 IRCT 2023-08-27 Samanik Salamat Gostar Company Assessing the effects of sachet containing white been extract, white burry extract, green coffee extract, Magnesium citrate and chromium picolinate and weight reduction in obese or overweight adults Assessing the effects of sachet containing famous vulgaris extract, Morus Alba leaf extract, Coffee robusta extract, Magnesium citrate and chromium picolinate and weight reduction diet compared to diet alone on weight loss in obese or overweight adults 2023-09-06 anticipated 80 Complete https://irct.ir/trial/72044 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants in the study are selected by convenience sampling method. Patients are classified according to age and gender, and each person will be placed in a group receiving supplementation or placebo using 1:1, quadruple random blocks. Quadruple blocks are randomly designed through software such as ...... (ABAB), (BBAB), (AABB), (ABBA), (BAAB). Assigning A or B to the supplement or placebo group will be done by someone outside the research so that the researchers remain blind. According to the list of randomly prepared quadruple blocks, a trained person outside the research team is responsible for randomly assigning patients. After each patient enters, according to the quadruple blocks prepared in the first stage, each patient is randomly assigned to group A or B. Assignment process will be done consecutively until the sampling is completed, Blinding description: It is a double blind study. Participants, research team including principle investigator, data collectors, and outcome assessors will be blind to supplement or placebo allocation. Blinding would be performed by a third person out of study team. Allocation data would be unavailable to study team till the end of data collection and analysis. 3 Overweight and Obesity. Intervention 1: Intervention group: The duration of intervention in this clinical trial will be 8 weeks. Beside calorie restricted diet (300-500 Kcal less than calculated daily energy need) people will receive one 5 gram sachet of supplement (each sachet contains 150 mg famous vulgaris extract, 200 mg Morus Alba leaf extract, 400 mg Coffee robusta extract, 100 mg Magnesium citrate and 50 mcg chromium picolinate ) (Samanic company). Intervention 2: Control group: The duration of intervention in this clinical trial will be 8 weeks. Beside calorie restricted diet (300-500 Kcal less than calculated daily energy need) people will receive one 5 gram-saceht of placebo contains maltodextrine (Samanic company). Yes - There is a plan to make this available What will be shared: Study protocol, and report of the main output of the study would be available in case of researchers' reasonable request sending to principal investigator of the study 6 months after publishing the article. When: starting 6 months after publication To whom: University researchers Conditions: Have no other condition Where to obtain: Email to soodehrazeghi@gmail.com How to obtain: Researches can email their enquery for study protocol, and report of the main output of the study with reasonable request, 6 months after publishing the article and will receive the date in 2 weeks. Comments:
public Soodeh Razghei Jahromi
No. 7, West Arghavan St., Farahzadi Blv., Qods Town
Tehran Iran (Islamic Republic of) 4741-19395 +98 21 2235 7483 soodehrazeghi@gmail.com Shahid Beheshti University of Medical Sciences scientific Soodeh Razghei Jahromi
No. 7, West Arghavan St., Farahzadi Blv., Qods Town
Tehran Iran (Islamic Republic of) 4741-19395 +98 21 2235 7483 soodehrazeghi@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Body mass index of 25-40 age of 16-65years Willing to participate 18 years 65 years Both Consuming weight reduction medications substance overuse Pregnancy and lactation Having known kidney disease Having known heart disease E66 Overweight and obesity Treatment - Other Placebo Intervention group: The duration of intervention in this clinical trial will be 8 weeks. Beside calorie restricted diet (300-500 Kcal less than calculated daily energy need) people will receive one 5 gram sachet of supplement (each sachet contains 150 mg famous vulgaris extract, 200 mg Morus Alba leaf extract, 400 mg Coffee robusta extract, 100 mg Magnesium citrate and 50 mcg chromium picolinate ) (Samanic company) Control group: The duration of intervention in this clinical trial will be 8 weeks. Beside calorie restricted diet (300-500 Kcal less than calculated daily energy need) people will receive one 5 gram-saceht of placebo contains maltodextrine (Samanic company). Weight. Timepoint: Baseline and after 2 months from the beginning of the study. Method of measurement: Scale. Fat mass. Timepoint: Baseline and after 2 months from the beginning of the study. Method of measurement: Omron BF511 body composition scale. Fat free mass. Timepoint: Baseline and after 2 months from the beginning of the study. Method of measurement: Omron BF511 body composition scale. Samanik Salamat Gostar Company Approved 2023-06-12 Ethics committee of National Nutrition and Food Technology Reseach Institute No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town Tehran Tehran Iran (Islamic Republic of)