Overweight or mildly obese individuals
Conditions
Interventions
Trial Group:Weight-loss meal plan + weight-loss exercise and dietary education
Control Group:Weight Loss Exercise and Diet Education
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18–40 years; 2. Overweight or mildly obese individuals: BMI >= 28 kg/m^2 and < 35 kg/m^2; 3. Able to comply with exercise and dietary requirements; 4. Capable of reading Chinese and accurately understanding the trial procedures, willing to participate in the trial, and having signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Severe cardiovascular, hepatic, pulmonary, or renal disease, or other severe organic diseases; 2. History of acute, chronic, or active gastrointestinal diseases; 3. Current use of medications known to affect body weight (e.g., orlistat, GLP-1 receptor agonists, metformin, etc.); 4. Individuals with a confirmed diagnosis of diabetes or currently taking antidiabetic medications; 5. Women who are currently pregnant or breastfeeding, or planning to become pregnant within the next three months; 6. Use of oral or intravenous antibiotics within the past month; 7. History of severe psychiatric disorders requiring regular treatment with psychotropic medications; 8. Patients with secondary or drug-induced obesity, including hypothalamic obesity, pituitary obesity, Cushing's syndrome, and obesity associated with hypogonadism; 9. Individuals with specific dietary habits, such as long-term strict vegetarians; 10. Body weight change exceeding 10% within the past three months; 11. Failure to meet inclusion criteria, noncompliance with prescribed intake of the test product, inability to assess efficacy due to insufficient data, or incomplete records affecting efficacy or safety evaluation; 12. Other individuals deemed unsuitable for participation in the trial based on clinical assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body Composition Analysis: Body Weight, BMI, Body Fat Percentage, Basal Metabolic Rate (BMR), Waist-to-Hip Ratio, Lean Body Mass (Fat-Free Mass);Abdominal CT: Total fat area (TFA), visceral fat area (VFA), and subcutaneous fat area (SFA) of the abdomen for visceral fat measurement;Metabolic regulation: blood glucose level, insulin level, insulin resistance index (HOMA-IR), and four lipid profile parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| Inflammatory markers: IL-6, IL-1ß, TNF-a;Hormone Levels: Serum Leptin, Adiponectin;Emotional Status Survey: Hospital Anxiety and Depression Scale (HADS);Appetite Status Survey: Chinese Version of the Dutch Eating Behavior Questionnaire;Physical Activity and Dietary Survey (Three Days Before and After the Trial);16S rDNA Sequencing: Analysis of Gut Microbiota Diversity;LC-MS Untargeted Metabolomics;SCFA Detection: GC-MS Analysis of Short-Chain Fatty Acid Content in Feces; | — |
Countries
China
Contacts
Public ContactZhou Huan
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed