NCT07759323

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

August 15, 2026

Expected
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2027

Last Updated

August 12, 2026

Status Verified

July 1, 2026

Enrollment Period

12 months

First QC Date

August 6, 2026

Last Update Submit

August 6, 2026

Conditions

Visceral ObesityMetabolic Syndrome

Keywords

Polygonatum sibiricumVisceral Fat Area

Outcome Measures

Primary Outcomes (1)

  • Change in visceral fat area

    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.

    Baseline and Week 12

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

Polygonatum sibiricum Intervention Group

EXPERIMENTAL

Polygonatum sibiricum and lifestyle intervention

Dietary Supplement: Polygonatum sibiricumBehavioral: Lifestyle Intervention

Control Group

ACTIVE COMPARATOR

Lifestyle intervention

Behavioral: Lifestyle Intervention

Interventions

Polygonatum sibiricumDIETARY_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.

Also known as: Huangjing
Polygonatum sibiricum Intervention Group
Lifestyle InterventionBEHAVIORAL

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.

Also known as: Standardized Lifestyle Intervention
Control GroupPolygonatum sibiricum Intervention Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Provincial Tongde Hospital

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Obesity, AbdominalMetabolic Syndrome

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Central Study Contacts

Xiaoli Wang, Ph.D.

CONTACT

+86 15168448356wxldoctor@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2026

First Posted

August 12, 2026

Study Start (Estimated)

August 15, 2026

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

July 30, 2027

Last Updated

August 12, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)