Clinical trial NCT06968208: The Efficacy and Safety of Puerarin in Obesity Treatment
Official title: Randomized Controlled Trial of Puerarin for Obesity Treatment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Metabolic Diseases
Obesity/Therapy
Keywords: Puerarin
Intestinal Lipid Absorption
Dorsal Motor Nucleus of Vagus (DMV)
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Body weight
timeFrame: Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.
measure: Body Fat Percentage
timeFrame: Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.
measure: Serum Lipid Profile (Total Cholesterol [TC], Triglycerides [TG])
timeFrame: Measurements will be performed at each timepoint (baseline, 1, 3, and 6 months post-intervention) and twice a day
measure: Fecal Lipids
timeFrame: Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.
Secondary outcomes:
measure: Blood Glucose
timeFrame: Measurements will be performed at each timepoint (baseline, 1, 3, and 6 months post-intervention) and twice a day
measure: Basal Metabolic Rate
timeFrame: Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.
measure: Gut Hormones
timeFrame: Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.
measure: Insulin level
timeFrame: Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.
measure: Gut Microbiome Metagenomics
timeFrame: Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention).
measure: C-Peptide
timeFrame: Measurements will be performed in quadruplicate at each timepoint (baseline, 1, 3, and 6 months post-intervention), with the mean value recorded.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
References: