Obese individuals with weight cycling.
Conditions
Interventions
Probiotic Group 1:WONDERLAB SHAPE100? Probiotic Ready-to-Eat Lactic Acid Bacteria Food (S100)
Probiotic Group 2:WONDERLAB S100+WONDERLAB Weight Management Probiotic Ready-to-Eat Lactic Acid Bacteria Food
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. People with obesity (28 =3 times) in the past 2 years, with weight fluctuations of more than 5% or more; 3. Age 18-60 years old (inclusive), male or female; 4. Have the ability to understand the weight loss program and voluntarily participate in the whole process of weight loss; 5. Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Individuals currently using medications known to affect body weight (e.g., orlistat, GLP-1 receptor agonists, metformin, etc.); 2.Individuals diagnosed with diabetes or using antihyperglycemic medications; 3.Patients with severe metabolic abnormalities: triglycerides exceeding 2.5 times the upper limit of normal, cholesterol exceeding 2.5 times the upper limit of normal; fasting whole blood glucose >11.1 mmol/L; uric acid exceeding 2 times the upper limit of normal; 4.Pregnant or breastfeeding individuals, or those planning to become pregnant within the next 3 months; 5.Individuals with severe cardiac, hepatic, pulmonary, renal, or other serious organic diseases; 6.Patients diagnosed with hyperthyroidism or hypothyroidism; 7.Individuals with a history of acute, chronic, or active gastrointestinal diseases; 8.Individuals who have used oral or intravenous antibiotics within the past month; 9.Individuals with a history of severe mental disorders requiring regular psychotropic medication; 10.Patients with secondary or drug-induced obesity: including hypothalamic obesity, pituitary obesity, Cushing’s syndrome, and hypogonadism-related obesity, among others; 11.Individuals with specific dietary habits, such as long-term strict vegetarians; 12.Individuals with a weight change exceeding 10% within the past 3 months; 13.Individuals deemed by the investigator to have poor compliance or inability to complete the weight loss process.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Appetite ;Changes in concentrations of GLU, INS, GHRL, GLP-1, LEP, PYY;Results of metabolomic analysis of blood;Body composition (body weight, waist, hips, arms, leg circumference, body fat percentage, muscle mass, basal metabolic rate, etc.);Metabolic regulation (TG, HDL-CH, LDL-CH, CHOL, apolipoprotein);Intestinal metagenomics;Gastrointestinal symptom score;Safety (blood routine, urine routine, liver and kidney function, electrolytes, incidence of adverse events);Adherence (weight diary check-in, sample bottle recovery, medication adherence assessment); | — |
Primary
| Measure | Time frame |
|---|---|
| The proportion of participants with a percentage of weight loss >5% after the 84-day intervention.; | — |
Countries
China
Contacts
Public ContactChen Wei
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed