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

Determinig 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

Clinical trial with placebo control group, with parallel groups, double blinded, randomized, on 80 individuals with overweight/obesity, randomization with blocks of size 4 using software

The place of the study:Shahid Fayazbakhsh Hospital in Tehran; Population: people with overweight and obesity; type of blinding: double blinded; blinding, randomization and preparation of supplement cans will be done by a trained person outside the study until participants, researchers and analyzer remain blind until the end of the analysis. At the beginning and end of the intervention with supplement or placebo weight, height, BMI, and body composition will be measured. Participants in both groups will receive weight loss diets based intervention with supplement/placebo during the study period. Study duration will be 8 weeks.

Inclusion criteria: BMI:25-40, age: 18-65 years, and willing to participate in the study. Exclusion criteria: Using weight reduction medication, substance overuse, pregnancy or lactation, having known kidney disease, and having known heart disease

Supplement group: One 5-gram sachet of saplement daily and weight reduction diet, Placebo group: One 5-g sachet of placebo and weight reduction diet for 8 weeks

weight; fat mass; fat free mass; BMI

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.

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.

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.

starting 6 months after publication

University researchers

Have no other condition

Email to soodehrazeghi@gmail.com

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.