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Metabolism of Bioactive Dietary Polyphenol Preparation (BDPP)

NCT04421079 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-03-03

No results posted yet for this study

Summary

This study will characterize the clinical pharmacology of a select bioactive polyphenol-rich preparation (Bioactive Dietary Polyphenol Preparation, BDPP) comprised of a select Concord grape juice (CGJ), a select grape seed polyphenol extract (GSPE) and trans-resveratrol (RSV).

Conditions

  • Healthy Control

Interventions

DIETARY_SUPPLEMENT

Trans-resveratrol

150mg, 300mg, 450mg

DIETARY_SUPPLEMENT

Concord grape juice

8 oz, 16 oz, 24 oz

DIETARY_SUPPLEMENT

Grape seed polyphenol extract

450mg, 900mg, 1200mg

DRUG

Placebo

Comparable placebo supplement which is manufactured according to GMP and will contain inert substances.

Sponsors & Collaborators

Principal Investigators

  • James Murrough, MD, PhD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-19
Primary Completion
2024-12-02
Completion
2024-12-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04421079 on ClinicalTrials.gov