Polygonatum Sibiricum Reduces Visceral Fat in Obese Adults

Sponsor
Zhejiang Provincial Tongde Hospital
Study ID
NCT07759323
Status
Not Yet Recruiting

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Conditions

  • Metabolic Syndrome
  • Visceral Obesity

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Polygonatum sibiricum — DIETARY_SUPPLEMENT
    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.
  • Lifestyle Intervention — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Aug 12, 2026
Start date
Aug 15, 2026
Status verified
Jul 2026
Primary completion
Jul 30, 2027
Completion
Jul 30, 2027

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Polygonatum sibiricum Intervention Group
    Polygonatum sibiricum and lifestyle intervention
  • Active Comparator: Control Group
    Lifestyle intervention

Primary Outcome Measure

Change in visceral fat area [ Time Frame: Baseline and Week 12 ]

Central Contacts

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