None
Conditions
Interventions
Intervention group:Probiotic product (10^10 CFU per day)
Control group:Placebo product (without probiotics, matching the probiotic product in appearance, taste, and dosage form)
Sponsors
School of Public Health (Shenzhen), Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Male and female participants aged 18-65 years; 2.Residents who have lived in the Guangdong area for more than 1 year; 3.With a Body Mass Index (BMI) of 24 to 35 kg/m^2, according to the standards for determining overweight and obesity in Chinese adults; 4.Males with a waist circumference of >=90 cm, and females with a waist circumference of >=85 cm; 5.Agree to be randomly assigned to the intervention group or the control group; 6.Willing to consume the probiotic product provided by the study; 7.Engage in low or moderate physical activity and agree not to change their current exercise routine throughout the duration of the study.
Exclusion criteria
Exclusion criteria: 1.Secondary obesity due to illness or medication; 2.Abnormal glucose metabolism, with fasting blood glucose levels >= 7.0 mmol/L, or currently using medications that affect glucose metabolism (oral hypoglycemic agents or insulin, etc.); 3.Familial hyperlipidemia, or currently using medications that affect cholesterol metabolism; 4.Currently suffering from untreated hypertension or using antihypertensive medications; 5.History of severe illness, or currently suffering from cardiovascular diseases (ischemic heart disease, heart failure, prolonged QTc interval, arrhythmias and conduction disorders—absolute arrhythmias, ventricular premature contractions, atrioventricular block), diabetes (Type 1 or Type 2), kidney, thyroid, gastrointestinal (inflammatory bowel disease, significant gastrointestinal bleeding, etc.), hepatobiliary, immune, respiratory, neurologic, musculoskeletal, psychiatric, infectious, and malignant tumors, and currently undergoing treatment or using related medications; 6.History of polycystic ovary syndrome in women; 7.Long-term or current use of non-steroidal anti-inflammatory drugs, antibiotics, antihistamines, or immunomodulatory drugs, and inability to discontinue these medications within 72 hours prior to the start of the study; 8.Currently using anticoagulants, anabolic steroids, hydrocortisone, or other hormonal medications; 9.Use of medications or supplements that affect weight (such as anorexiants, antidepressants, beta-blockers, diuretics, hormonal contraceptives, and steroids) within 3 months prior to participation and during the study period, and unwillingness to discontinue; 10.Use of probiotics, multivitamins, antioxidants, fish oil, herbal supplements, dietary fiber supplements, and other nutritional supplements (such as inulin, fish oil, soy lecithin, niacin, dietary fiber, flaxseed, phytoestrogens, sterols, etc.) or products containing prebiotics, probiotics, synbiotics, postbiotics, etc. (such as yogurt, fermented milk, beverages, or other fermented products, etc.) with a frequency of at least once a week within 30 days prior to participation, and unwillingness to discontinue during the study period; 11.History of surgery (such as endometrial ablation), or history of weight loss surgery (such as gastric bypass, bariatric surgery, or intestinal resection); 12.Participation in commercial weight loss programs, medication weight loss, dietary control programs (such as low-calorie diets), or other weight loss methods within 3 months prior to participation or currently engaged in such activities; 13.Self-reported weight loss of more than 7 kg or 5% within 6 months prior to enrollment; 14.Unwillingness to experience weight changes throughout the study period; 15.Vegetarian diet; 16.History of depression, eating disorders such as anorexia and bulimia; 17.Presence of eating behavior disorders, dysphagia, or difficulty swallowing food or medication; 18.Lactose intolerance; 19.Inability to consume the study-provided probiotic product as required during the study period; 20.Consumption of more than 2 alcoholic drinks per day, or more than 14 times per week, and unwillingness to cease alcohol consumption during the study; 21.Intolerance or allergies to the study product, food allergies, drug allergies, or other issues that may affect food intake; 22.Difficulty with venous blood draws; 23.Women who have given birth within the past year, are pregnant, or plan to become pregnant within 6 months, or are breastfeeding; 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Waist circumference;Weight;Waist-to-hip ratio;Body mass index;Body composition; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum insulin level;Blood glucose level;Blood lipid profile;Hormones of the gastrointestinal tract level;Blood inflammatory cytokine levels;Obesity-Related hormones levels;Fecal microbiota diversity and composition;Fecal short-chain fatty acid levels;Fecal bile acid levels;Peripheral blood mononuclear cell transcriptome; | — |
Countries
China
Contacts
Public ContactYaoqing Chen
School of Public Health (Shenzhen), Sun Yat-sen University
Outcome results
None listed