Visceral ObesityNCT07759323
Polygonatum Sibiricum Reduces Visceral Fat in Obese Adults
A study testing Polygonatum sibiricum and Lifestyle Intervention in people with Visceral Obesity and Metabolic Syndrome, run by Zhejiang Provincial Tongde Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Visceral Obesity, Metabolic Syndrome
- What is being tested?
- Polygonatum sibiricum and Lifestyle Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2026to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhejiang Provincial Tongde Hospital
Hangzhou, Zhejiang
Xiaoli Wang, Ph.D., +86 15168448356, wxldoctor@126.com
About this study
Official title: Polygonatum Sibiricum for Visceral Obesity and Related Metabolic Abnormalities: A Randomized Controlled Trial and Mechanistic Exploration
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.
Read more
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.
- Conditions
- Visceral Obesity, Metabolic Syndrome
- Being tested
- Polygonatum sibiricum, Lifestyle Intervention
- Keywords
- Polygonatum sibiricum, Visceral Fat Area
- Medical subject headings
- Obesity, Abdominal, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polygonatum sibiricumDietary supplement
Also called Huangjing
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 InterventionBehavioural
Also called Standardized Lifestyle 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.
| Study group | Role | What they receive |
|---|---|---|
| Polygonatum sibiricum Intervention Group | Experimental | Polygonatum sibiricum and lifestyle intervention Receives: Dietary Supplement: Polygonatum sibiricum; Behavioral: Lifestyle Intervention |
| Control Group | Active comparator | Lifestyle intervention Receives: Behavioral: Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 12
Secondary outcomes (8)
Body weight
Measured: Baseline and Week 12
waist circumference
Measured: Baseline and Week 12
body fat rate
Measured: Baseline and Week 12
Blood lipids
Measured: Baseline and Week 12
fasting blood glucose
Measured: Baseline and Week 12
fasting insulin
Measured: Baseline and Week 12
HOMA-IR
Measured: Baseline and Week 12
degree of hepatic steatosis
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start15 Aug 2026 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visceral ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial Tongde Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759323
- Sponsor's protocol ID
- 2026TD-ZYYZ0005
- Status last verified
- Jul 2026
- First submitted
- 6 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polygonatum Sibiricum for Visceral Obesity and Related Metabolic Abnormalities: A Randomized Controlled Trial and Mechanistic Exploration
- ClinicalTrials.gov ID
- NCT07759323
- Acronym / sponsor ID
- 2026TD-ZYYZ0005
- Conditions
- Visceral Obesity, Metabolic Syndrome
- Keywords
- Polygonatum sibiricum, Visceral Fat Area
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Zhejiang Provincial Tongde HospitalUniversity, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polygonatum sibiricum Intervention Group | Experimental | Dietary Supplement: Polygonatum sibiricum, Behavioral: Lifestyle InterventionPolygonatum sibiricum and lifestyle intervention |
| Control Group | Active comparator | Behavioral: Lifestyle InterventionLifestyle intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polygonatum sibiricumAlso: HuangjingPolygonatum 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. | Dietary supplement | Polygonatum sibiricum Intervention Group |
| Lifestyle InterventionAlso: Standardized Lifestyle InterventionStandardized 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. | Behavioural | Control Group, Polygonatum sibiricum Intervention Group |
Primary outcome
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.
8 secondary outcomes
Body weight
Time frame: Baseline and Week 12
waist circumference
Time frame: Baseline and Week 12
body fat rate
Time frame: Baseline and Week 12
Blood lipids
Time frame: Baseline and Week 12
fasting blood glucose
Time frame: Baseline and Week 12
fasting insulin
Time frame: Baseline and Week 12
HOMA-IR
Time frame: Baseline and Week 12
degree of hepatic steatosis
Time frame: Baseline and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polygonatum sibiricum and Lifestyle Intervention in people with Visceral Obesity and Metabolic Syndrome, run by Zhejiang Provincial Tongde Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoli Wang, Ph.D. (+86 15168448356, wxldoctor@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in visceral fat area (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.