Overweight and obesity. Overweight and obesity
Conditions
Interventions
Intervention 1: Intervention group: Weight loss program (diet + physical activity recommendations) + daily consumption of synbiotic beverage powder supplement containing pasteurized Akkermansia mucini
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactParastoo Asghari
Mashhad University of Medical Sciences
Outcome results
None listed