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IRCT20140804018677N25 IRCT 2023-03-29 Takin Pars pharmed Company Effects of Slimtak (Combination of green tea dry extract and Cichorium intybus roots Extract) on weight loss in obese or overweight adults Effects of Slimtak (Combination of green tea dry extract and Cichorium intybus roots Extract) compared to placebo on weight loss in obese or overweight adults 2023-04-03 anticipated 80 Complete https://irct.ir/trial/69261 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 3 capsules of Slimtack (each capsules contains 200 mg green tea dry extract and 80 mg Cichorium intybus roots Extract) (Takin Pars pharmed company) with each meal. 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 3 capsoules of placebo (each capsouls contains 500 mg corn starch) (Takin Pars pharmed company) with each meal. Yes - There is a plan to make this available What will be shared: Coded data of the participants, 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: sending email 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 3 capsules of Slimtack (each capsules contains 200 mg green tea dry extract and 80 mg Cichorium intybus roots Extract) (Takin Pars pharmed company) with each meal. 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 3 capsoules of placebo (each capsouls contains 500 mg corn starch) (Takin Pars pharmed company) with each meal. 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. Takin Pars pharmed Company Approved 2023-01-22 Research Ethics committees of National Nutrition & Food Technology Research Institute No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town Tehran Tehran Iran (Islamic Republic of)