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This randomized controlled trial aims to evaluate the therapeutic efficacy of puerarin intervention in weight management and metabolic regulation among obese populations. The study will systematically address two primary endpoints: 1) The capacity of puerarin to induce clinically significant body weight reduction in individuals with BMI ≥30 kg/m²; 2) Its modulatory effects on postprandial lipid metabolism as measured by serum lipids and quantitative fecal lipid excretion analysis. Secondary outcomes focus on puerarin's pleiotropic effects, including continuous glucose monitoring-derived glycemic parameters and indirect calorimetry-assessed resting metabolic rate. Secondary exploratory objectives include investigating puerarin's potential mechanisms of action through continuous glucose monitoring and indirect calorimetry measurements to assess glycemic variability and resting energy expenditure, respectively. Participants will be randomized into two parallel groups: the intervention group receiving daily oral puerarin injection (75 mg/day, dissolved in 100 mL of 0.9% sodium chloride solution) and the control group receiving matched blank 100 mL of 0.9% sodium chloride solution, both administered double-blind for 6 consecutive months. Primary efficacy endpoints (body weight, waist circumference, lipid profile) and safety monitoring (adverse events, hematological/ biochemical parameters) will be assessed at baseline, 1, 3, and 6 months post-intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Puerarin Group | Experimental |
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| Placebo Group | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Puerarin | Drug | 75 mg of puerarin injection, dissolved in 0.9% sodium chloride solution. The puerarin injection is manufactured under Good Manufacturing Practice (GMP) conditions by [Harbin Medisan Pharmaceutical Co., Ltd.], with identical appearance, size, and packaging to the blank 0.9% sodium chloride solution to ensure blinding. Stability testing confirms integrity under standard storage conditions (25°C, 60% RH). |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Body weight will be measured to the nearest 0.1 kg using a calibrated digital scale under standardized conditions: participants in lightweight clothing (hospital gown), barefoot, and after an overnight fast (≥8 hours). | Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded. |
| Body Fat Percentage | Body fat percentage will be quantified via bioelectrical impedance analysis (BIA, InBody 770®). | Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded. |
| Serum Lipid Profile (Total Cholesterol [TC], Triglycerides [TG]) | Total Cholesterol (TC): Measured via cholesterol oxidase-peroxidase method, traceable to CDC reference standards. Triglycerides (TG): Quantified using glycerol-3-phosphate oxidase method with correction for free glycerol. The blood samples will be collected before and 2 hours after meals. | Measurements will be performed at each timepoint (baseline, 1, 3, and 6 months post-intervention) and twice a day |
| Fecal Lipids | Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Glucose | The blood samples will be collected after overnight fasting and 2 hours after meals. | Measurements will be performed at each timepoint (baseline, 1, 3, and 6 months post-intervention) and twice a day |
| Basal Metabolic Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiqiu Wang, PhD, Principal Investigator | Contact | +86-153-0048-3751 | wangjg@shsmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200000 | China |
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| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| C033607 | puerarin |
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This study utilizes a randomized, double-blind, placebo-controlled, parallel-group design. Participants will be allocated 1:1 to either the intervention group receiving daily oral puerarin (75 mg/day, dissolved in 100 mL of 0.9% sodium chloride solution) or the control group receiving identically matched blank 100 mL of 0.9% sodium chloride solution for 6 consecutive months. Randomization will be stratified by baseline body mass index (BMI) and performed via a centralized computer-generated sequence with allocation concealment. Both participants and investigators will remain blinded to treatment assignment throughout the trial. Primary efficacy endpoints (body weight reduction, waist circumference, and lipid profile improvement) and safety outcomes (adverse events, hematological/biochemical parameters) will be assessed at baseline, 1, 3, and 6 months post-randomization. The study adheres to CONSORT guidelines for clinical trial reporting.
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| Placebo | Drug | 0.9% sodium chloride solution formulated to match the appearance, size, and taste of the active puerarin solution, with no other active pharmaceutical ingredients. 0.9% sodium chloride solution is manufactured under identical Good Manufacturing Practiceconditions by [Shijiazhuang No.4 Pharmaceutical Co., Ltd.] and changed to the same batch processes and packaging as the intervention group. Stability testing confirms equivalent integrity under standard storage conditions (25°C, 60% RH). Blinding is ensured through indistinguishable outer packing characteristics and labeling. |
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Basal metabolic rate will be measured via indirect calorimetry using a validated metabolic cart under strictly standardized conditions: participants in a fasting state (≥12 hours overnight), resting supine in a thermoneutral environment (22-24°C), with 30 minutes of pre-measurement rest and avoidance of caffeine or vigorous activity for 24 hours prior.
| Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded. |
| Gut Hormones | Like ghrelin, cholecystokinin (CCK), Glucagon-like peptide-1 (GLP-1), Peptide YY (PYY) | Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded. |
| Insulin level | The blood samples will be collected after overnight fasting(>8 hors). | Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded. |
| Gut Microbiome Metagenomics | Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention). |
| C-Peptide | The blood samples will be collected after overnight fasting(>8 hors). | Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |