Effect of Puerarin on Heart Health in Men

NCT03676296 | Completed Phase 2 DMC

• 1 other identifier: NCD001.0
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the effect of puerarin supplementation on cardiovascular disease risk factors in men.

Conditions

Cardiovascular Disease Risk Factors

Keywords

Puerarin; Lipids; Testosterone

Outcome Measures

Primary Outcomes (4)

• Change in total cholesterol

  Mean difference in total cholesterol (mmol/L)

  Baseline, 12 weeks, 16 weeks and 28 weeks

• Change in low density lipoprotein (LDL) cholesterol

  Mean difference in LDL cholesterol (mmol/L)

  Baseline, 12 weeks, 16 weeks and 28 weeks

• Change in high density lipoprotein (HDL) cholesterol

  Mean difference in HDL cholesterol (mmol/L)

  Baseline, 12 weeks, 16 weeks and 28 weeks

• Change in triglycerides

  Mean difference in triglycerides (mmol/L)

  Baseline, 12 weeks, 16 weeks and 28 weeks

Secondary Outcomes (3)

• Change in blood pressure

  Baseline, 12 weeks, 16 weeks and 28 weeks

• Change in fasting glucose

  Baseline, 12 weeks, 16 weeks and 28 weeks

• Change in testosterone

  Baseline, 12 weeks, 16 weeks and 28 weeks

Study Arms (2)

Puerarin

EXPERIMENTAL

Puerarin (90.2 mg daily) in granules

Drug: Puerarin; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Placebo in granules

Drug: Puerarin; Drug: Placebo

Interventions

Puerarin DRUG

Puerarin (90.2 mg daily) in granules (as well as excipients) taken orally for 12 weeks

Placebo; Puerarin

Placebo DRUG

Placebo in granules (with the same excipients as the puerarin supplement but without puerarin) taken orally for 12 weeks

Placebo; Puerarin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men
• Aged 18 to 50 years
• Chinese ethnicity
• Willing to make return visits
• Not currently taking any traditional Chinese medicine (including puerarin) supplementation
• Not currently receiving hormone replacement therapy, such as testosterone replacement therapy, in the past 12 months
• Free of any congenital diseases
• Free of any infectious diseases e.g. seasonal influenza
• With no history of any chronic diseases including coronary heart disease (ischemic heart disease), myocardial infarction (heart attack), stroke, diabetes and cancer
• Have a 10-year risk of ischemic heart disease of less than 10%

You may not qualify if:

• Women

Sponsors & Collaborators

• The University of Hong Kong: lead
• Health and Medical Research Fund: collaborator

Study Sites (1)

The University of Hong Kong

Hong Kong, China

Location

MeSH Terms

Interventions

puerarin

Study Officials

• Gabriel M Leung, M.D.

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 18, 2018
• Study Start: September 5, 2018
• Primary Completion: April 17, 2021
• Study Completion: April 17, 2021
• Last Updated: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)