Metabolic Syndrome, Visceral Obesity
Conditions
Keywords
Polygonatum sibiricum, Visceral Fat Area
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.
Interventions
DIETARY_SUPPLEMENTPolygonatum sibiricum
Polygonatum sibiricum decoction, 15 g daily, taken orally in 1-2 divided doses after meals, for 12 consecutive weeks. The herbal decoction is prepared by the Pharmaceutical Department of Zhejiang Provincial Tongde Hospital from authenticated Polygonatum sibiricum raw material. Batch number management, dispensing logs, and residual drug recovery are implemented to ensure traceability. All participants in this arm also receive standardized lifestyle intervention (individualized calorie-restricted diet, moderate-intensity aerobic combined with resistance exercise for at least 150 minutes per week, and Traditional Chinese Medicine behavioral guidance). The study is a randomized, open-label, parallel-controlled trial designed to evaluate the effects of Polygonatum sibiricum on visceral fat area and related metabolic parameters.
BEHAVIORALLifestyle Intervention
Standardized lifestyle intervention consisting of three components: (1) individualized calorie-restricted diet prescribed by a dietitian based on each participant's basal metabolic rate and physical activity level, following the principles of total energy control, reduced sugar and fat intake, and regular meals; (2) moderate-intensity aerobic exercise combined with resistance training, with a target of at least 150 minutes per week; and (3) Traditional Chinese Medicine "preventive treatment" behavioral guidance, including sleep management, stress management, and daily living and dietary education. This intervention is provided to all participants in both groups throughout the 12-week study period.
Sponsors
Zhejiang Provincial Tongde Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in visceral fat area | 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
| Measure | Time frame |
|---|---|
| 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 |
| fasting insulin | Baseline and Week 12 |
| HOMA-IR | Baseline and Week 12 |
| degree of hepatic steatosis | Baseline and Week 12 |
Countries
China
Contacts
CONTACTXiaoli Wang, Ph.D.
Outcome results
None listed