The Efficacy and Safety of Puerarin in Obesity Treatment

Phase 2

Not yet recruiting

• Conditions: Metabolic Diseases; Obesity/Therapy
• Interventions: Drug: Puerarin; Drug: Placebo

• Registration Number: NCT06968208
• Lead Sponsor: Ruijin Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-05-05
• Study First Submitted QC: 2025-05-05
• Study First Posted: 2025-05-13
• Last Update Submitted: 2025-05-18
• Last Update Posted: 2025-05-21
• Study Start: 2025-08-01
• Primary Completion: 2029-01-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Aged 18-60 years (inclusive), any gender.
2. Obesity (BMI ≥30.0 kg/m²).
3. With or without obesity-related metabolic comorbidities (e.g., type 2 diabetes, hypertension, dyslipidemia, hyperuricemia).
4. No prior use of weight-control, glucose-lowering, or lipid-modifying medications.
5. Stable weight (<3% fluctuation) and lifestyle for ≥1 month prior to screening.
6. Fully informed of trial objectives, procedures, risks, and benefits; voluntarily signed informed consent form.

Exclusion Criteria

1. Secondary causes of obesity (e.g., monogenic obesity, Cushing's syndrome, drug-induced obesity).
2. History of common nutrient allergies (e.g., gluten, milk, eggs, plant-derived proteins).
3. Use of weight-control medications (e.g., metformin, GLP-1 receptor agonists, orlistat), corticosteroids (oral/IV/IM/non-oral systemic/intra-articular), or metabolic-interfering drugs/supplements within 3 months prior to screening or during the trial.
4. Use of traditional Chinese medicines or herbal products for weight management within 3 months prior to screening or during the trial.
5. History of psychiatric disorders, epilepsy, antidepressant use, or ongoing antiepileptic therapy.
6. Pregnancy, lactation, or plans for pregnancy within 6 months post-trial.
7. Active infectious diseases (e.g., HBV, HCV, tuberculosis, syphilis, HIV).
8. Severe infections, severe anemia (Hb <8 g/dL), or neutropenia (ANC <1.5×10⁹/L).
9. Gastrointestinal surgery within 1 year (excluding appendectomy/hernia repair) or major non-GI surgery within 6 months.
10. Active substance/alcohol abuse.
11. Known hypersensitivity to trial drug components or history of severe drug allergies.
12. Severe cardiac disorders (e.g., congenital/rheumatic heart disease, cardiomyopathy [NYHA ≥III], coronary stenting).
13. Hyperthyroidism or hypothyroidism.
14. History of malignancies (treated/untreated), regardless of recurrence status.
15. Hepatic/renal dysfunction: ALT/AST ≥2.5×ULN, serum creatinine >ULN, or eGFR <60 mL/min/1.73m² (MDRD formula).
16. Gastrointestinal disorders affecting absorption (e.g., IBD, active ulcers, severe diarrhea/constipation).
17. Participation in other clinical trials within 3 months prior to screening.
18. Any condition deemed unsuitable by investigators.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Puerarin Group	Puerarin	1. Diet Stabilization (Days 0-3): Standardized high-fat isocaloric diet (25% carbs, 58% fat, 17% protein) to normalize baseline metabolic status. 2. Intervention Period (6 months): Participants will receive oral administration of 75 mg puerarin dissolved in 0.9% sodium chloride solution, taken 30 minutes before lunch
Placebo Group	Placebo	1. Diet Stabilization (Days 0-3): Standardized high-fat isocaloric diet (25% carbs, 58% fat, 17% protein) to normalize baseline metabolic status. 2. Intervention Period (6 months): Participants will receive oral administration of one matching blank 0.9% sodium chloride solution, taken 30 minutes before lunch. Blank injections are identical in appearance, taste, and packaging to the active puerarin injections but contain no active ingredients.

Primary Outcome Measures

Name	Time	Method
Body weight	Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.	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).
Body Fat Percentage	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 will be quantified via bioelectrical impedance analysis (BIA, InBody 770®).
Serum Lipid Profile (Total Cholesterol [TC], Triglycerides [TG])	Measurements will be performed at each timepoint (baseline, 1, 3, and 6 months post-intervention) and twice a day	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.
Fecal Lipids	Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.

Secondary Outcome Measures

Name	Time	Method
Blood Glucose	Measurements will be performed at each timepoint (baseline, 1, 3, and 6 months post-intervention) and twice a day	The blood samples will be collected after overnight fasting and 2 hours after meals.
Gut Microbiome Metagenomics	Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention).
C-Peptide	Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.	The blood samples will be collected after overnight fasting(\>8 hors).
Basal Metabolic Rate	Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.	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.
Gut Hormones	Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.	Like ghrelin, cholecystokinin (CCK), Glucagon-like peptide-1 (GLP-1), Peptide YY (PYY)
Insulin level	Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.	The blood samples will be collected after overnight fasting(\>8 hors).

Trial Locations

Locations (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China