Polygonatum Sibiricum for Visceral Obesity and Related Metabolic Abnormalities: A Randomized Controlled Trial and Mechanistic Exploration
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Change in visceral fat area
Study Overview
Brief Summary
This study is being done to find out if a traditional Chinese herb called Polygonatum sibiricum (Huangjing) can help reduce belly fat and improve metabolic health in adults with visceral obesity.
Visceral obesity means having too much fat stored deep inside the belly, around the organs. This type of fat is linked to a higher risk of diabetes, fatty liver, and heart disease.
The study will include 66 adults with visceral obesity. Participants will be randomly assigned to one of two groups:
One group will receive a Polygonatum sibiricum decoction (15 grams daily) plus standard lifestyle advice on diet and exercise.
The other group will receive the same lifestyle advice only.
The study will last for 12 weeks. Researchers will measure changes in visceral fat area, body weight, waist size, blood sugar, blood lipids, and liver fat. They will also look at gut bacteria and related markers to better understand how Polygonatum sibiricum might work.
Participation involves 4 visits to the study site over the 12-week period. All participants will receive free health assessments and dietitian guidance. The study is not a treatment but a research study to test whether this herb has potential benefits for visceral obesity.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 to 65 years, male or female;
- •Body mass index (BMI) ≥ 24 kg/m², or body fat percentage ≥ 25% for males or ≥ 30% for females, and visceral fat area ≥ 100 cm²;
- •Body weight stable within the past 3 months, with fluctuation not exceeding 5%;
- •Able to understand the study content, voluntarily sign the informed consent form, and willing to complete follow-up visits and required examinations as scheduled.
Exclusion Criteria
- •Secondary obesity (e.g., caused by endocrine disorders such as hypothyroidism, Cushing's syndrome, or polycystic ovary syndrome);
- •Previous metabolic surgery or current use of weight-loss medications;
- •Concomitant severe hyperglycemia or lipid metabolism disorders requiring immediate intensive treatment;
- •Concomitant severe cardiovascular or cerebrovascular disease, or unstable medical condition;
- •Significant hepatic or renal dysfunction (e.g., ALT or AST > 2-3 times the upper limit of normal, or eGFR < 60 ml/min/1.73 m²);
- •Malignant tumors, active infections, or autoimmune diseases;
- •Use of antibiotics, probiotics, or other agents that may affect gut microbiota within the past month;
- •Pregnancy, lactation, or plans for pregnancy;
- •Allergy to or intolerance of any component of the investigational product;
- •Any other conditions deemed unsuitable for participation in this study by the investigator.
Arms & Interventions
Polygonatum sibiricum Intervention Group
Polygonatum sibiricum and lifestyle intervention
Intervention: Polygonatum sibiricum (Dietary Supplement)
Polygonatum sibiricum Intervention Group
Polygonatum sibiricum and lifestyle intervention
Intervention: Lifestyle Intervention (Behavioral)
Control Group
Lifestyle intervention
Intervention: Lifestyle Intervention (Behavioral)
Outcomes
Primary Outcomes
Change in visceral fat area
Time Frame: Baseline and Week 12
Using bioelectrical impedance analysis (BIA), the change in visceral fat area after 12 weeks of intervention compared to the baseline was measured to evaluate the intervention effect of rehmannia on visceral fat accumulation.
Secondary Outcomes
- fasting insulin(Baseline and Week 12)
- HOMA-IR(Baseline and Week 12)
- degree of hepatic steatosis(Baseline and Week 12)
- Body weight(Baseline and Week 12)
- waist circumference(Baseline and Week 12)
- body fat rate(Baseline and Week 12)
- Blood lipids(Baseline and Week 12)
- fasting blood glucose(Baseline and Week 12)