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IRCT20250222064807N2 IRCT 2025-03-26 Mashhad University of Medical Sciences Investigating the effect of synbiotic supplement (containing pasteurized Akkermansia muciniphila, green tea extract and glucomannan konjac gum) on overweight or obesity investigating the effect of synbiotic supplementation on anthropometric indices and body composition in overweight or obese adults: A randomized, triple-blind, placebo-controlled clinical trial 2025-06-22 anticipated 72 Complete https://irct.ir/trial/82508 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using random allocation software, a list of random blocks of 6 blocks of 6 is designed and a number is assigned to each block. The order of the contents of each block ensures a balanced allocation of individuals in the study groups. With each patient's visit, one of the blocks is randomly selected and the patient is assigned to one of the groups according to the order of its contents, Blinding description: In this triple-blind study, participants, main researchers, physicians, observers, data collection officials, evaluators, as well as data analyzers are unaware that each person participating in the study group is in the main intervention group (supplementation of the synbiotic) or placebo. For blinding, symbiotic supplements and placebo will be similar in appearance, packaging and labeling. The process of packing and coding of the supplement and placebo will be carried out by the manufacturer (Parsi Lact company). N/A Overweight and obesity. Intervention 1: Intervention group: Weight loss program (diet + physical activity recommendations) + daily consumption of synbiotic beverage powder supplement containing pasteurized Akkermansia muciniphila, green tea extract, and konjac glucomannan gum (provided by Parsi Lact Company) (one sachet half an hour before every meal with sufficient amounts of water) for two months. Intervention 2: Control group: Weight loss program (diet + physical activity recommendations) + daily consumption of placebo (Microcrystalline cellulose) (with the same color, taste, and appearance) (provided by Parsi Lact Company) (one sachet half an hour before every meal with sufficient amounts of water) for two months. Yes - There is a plan to make this available What will be shared: Non-identifiable personal information of participants in this study will be shared. The protocol, results, and statistical analysis of the study will also be published in relevant articles. When: Access to data will begin 6 months after the results are published. To whom: Participants' non-identifiable personal information will then be made available to other researchers at academic institutions. Conditions: Participants' non-identifiable personal information can only be used for research aspects. Where to obtain: Non-identifiable information about participants can be obtained by sending an email to Dr. Saeideh Talebi (talebis@mums.ac.ir). How to obtain: Other researchers at academic institutions can send their requests via email to Dr. Saeideh Talebi. The data will be sent to them after consultation and approval by the research team. Comments:
public Parastoo Asghari
Faculty of Medicine, Eastern Gate of the University Campus, Azadi Square, Mashhad, Razavi Khorasan
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2000 AsghariP4022@mums.ac.ir Mashhad University of Medical Sciences scientific Parastoo Asghari
Faculty of Medicine, Eastern Gate of the University Campus, Azadi Square, Mashhad, Razavi Khorasan
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2000 AsghariP4022@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Adults aged 18 to 45 years Body mass index in the overweight or obese range (27-34.9) Waist circumference greater than 88 cm in women and greater than 102 cm in men Maintaining a stable weight (no weight gain or loss of more than 5% in the past 3 months) With informed consent 18 years 45 years Both Pregnant, lactating and postmenopausal women Confirmed or clinical history of eating disorders, gastrointestinal diseases, cardiovascular, hepatic, renal, pulmonary, endocrine diseases (thyroid, diabetes, etc.), cancer or any serious acute or chronic disease Current addiction to cigarettes, drugs or alcohol Presence of known allergies or sensitivities to supplement and placebo components History of bariatric surgery People who skip at least one of their meals Following a special diet, such as a vegetarian diet Regular consumption of more than 300 mg of caffeine or more than 30 g of fiber per day Regular consumption of Pro-, Pre-, and Synbiotic Food products Following a calorie-restricted diet for three months prior to the start of the study Taking probiotics, prebiotics, synbiotics or antibiotics within one month before the start of the study Consuming medications including cholesterol and lipid lowering drugs (statins, etc.), blood sugar lowering drugs (insulin, metformin, liraglutide, etc.), blood pressure lowering drugs (angiotensin II receptor blockers, beta blockers, calcium channel blockers, alpha blockers), drugs affecting weight and body composition, appetite such as antipsychotic drugs, corticosteroids, anti-obesity drugs, drugs affecting GI function Consuming weight loss supplements (including supplements affecting appetite, metabolism, food absorption) such as orlistat Consuming medications that interact with green tea: anisindione, atorvastatin, bortezomib, dicoumarol, digoxin, fusolent, lisinopril, nadolol, rosuvastatin, simvastatin, tacrolimus, tamoxifen, tirzepatide, warfarin professional athletes or those experiencing variations in the intensity and quantity of physical activity over the past four weeks E66 Overweight and obesity Treatment - Other Placebo Intervention group: Weight loss program (diet + physical activity recommendations) + daily consumption of synbiotic beverage powder supplement containing pasteurized Akkermansia muciniphila, green tea extract, and konjac glucomannan gum (provided by Parsi Lact Company) (one sachet half an hour before every meal with sufficient amounts of water) for two months. Control group: Weight loss program (diet + physical activity recommendations) + daily consumption of placebo (Microcrystalline cellulose) (with the same color, taste, and appearance) (provided by Parsi Lact Company) (one sachet half an hour before every meal with sufficient amounts of water) for two months Anthropometric parameters: weight - waist and hip circumference - waist-to-hip ratio - body mass index. Timepoint: Before, in the middle and at the end of the study. Method of measurement: Scale (with an accuracy of 0.1 kg) - meter. Body composition: body fat percentage, fat mass, fat free mass, etc. Timepoint: Before, in the middle and at the end of the study. Method of measurement: BIA. Metabolic parameters (fasting blood sugar, lipid profile: TC-TG-HDL-LDL). Timepoint: Before and at the end of the study. Method of measurement: Laboratory methods. Appetite sensation. Timepoint: Before, in the middle and at the end of the study. Method of measurement: visual analog scale. Physical activity. Timepoint: Before, middle and at the end of the study. Method of measurement: International physical activity questionnaire. Dietary intake. Timepoint: Before, middle and at the end of the study. Method of measurement: 24 hour dietary recall. Gastrointestinal symptoms. Timepoint: Before, middle and at the end of the study. Method of measurement: Gastrointestinal symptom rating scale. Blood pressure. Timepoint: Before and at the end of the study. Method of measurement: Electric blood pressure monitor. Mashhad University of Medical Sciences Approved 2025-02-04 Research Ethics Working Group/Committee, Faculty of Medicine, Mashhad University of Medical Sciences Faculty of Medicine, Eastern Gate of the University Campus, Azadi Square, Mashhad, Razavi Khorasan Mashhad Razavi Khorasan Iran (Islamic Republic of)