Metabolism of Bioactive Dietary Polyphenol Preparation (BDPP)

NCT04421079 | Completed Phase 1 FDA Drug

• 2 other identifiers: GCO 19-08481U19AT010835-01
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Polyphenol; Dietary Supplement

Outcome Measures

Primary Outcomes (1)

• DHCA level

  Bioavailability assessed to show a dose-dependent increase in key BDPP metabolites, including DHCA.

  up to Week 5

Secondary Outcomes (1)

• IL-6 levels

  up to Week 5

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Comparable placebos

Drug: Placebo

Low Dose BDPP

ACTIVE COMPARATOR

8 oz. Concord grape juice + 450 mg Grape seed polyphenol extract + 150 mg Trans-resveratrol

Dietary Supplement: Trans-resveratrol; Dietary Supplement: Concord grape juice; Dietary Supplement: Grape seed polyphenol extract

Medium Dose BDPP

ACTIVE COMPARATOR

16 oz. Concord grape juice + 900 mg Grape seed polyphenol extract + 300 mg Trans-resveratrol

Dietary Supplement: Trans-resveratrol; Dietary Supplement: Concord grape juice; Dietary Supplement: Grape seed polyphenol extract

High Dose BDPP

ACTIVE COMPARATOR

24 oz. Concord grape juice + 1200mg Grape seed polyphenol extract + 450mg Trans-resveratrol

Dietary Supplement: Trans-resveratrol; Dietary Supplement: Concord grape juice; Dietary Supplement: Grape seed polyphenol extract

Interventions

Trans-resveratrol DIETARY_SUPPLEMENT

150mg, 300mg, 450mg

High Dose BDPP; Low Dose BDPP; Medium Dose BDPP

Concord grape juice DIETARY_SUPPLEMENT

8 oz, 16 oz, 24 oz

High Dose BDPP; Low Dose BDPP; Medium Dose BDPP

Grape seed polyphenol extract DIETARY_SUPPLEMENT

450mg, 900mg, 1200mg

High Dose BDPP; Low Dose BDPP; Medium Dose BDPP

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female aged 18-55 years;
• Body max index (BMI) \<30;
• Participants must have a level of understanding of the English language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process.
• Including Spanish speaking participants

You may not qualify if:

• Any psychiatric diagnosis as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
• Subjects who meet criteria for a substance or alcohol use disorder in the past 2 years;
• Female participants who are pregnant or nursing or plan to become pregnant;
• Any unstable medical illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease); endocrinologic, neurologic, immunologic, or hematologic disease;
• Clinically significant abnormalities of laboratory tests, physical examination, or electrocardiogram;
• Any diagnosed inflammatory or autoimmune disorder, including but not limited to rheumatoid arthritis, ankylosing spondylitis, myositis, vasculitis, systemic lupus erythematosus, Sjogren's Syndrome, or scleroderma;
• Any use of medication or nutritional supplement known to affect inflammation, including but not limited to non-steroidal anti-inflammatory agents (NSAIDs), aspirin, acetaminophen, COX-2 selective inhibitors, omega-3 fatty acids, turmeric extract, ginger extract, vitamin E, and "Devil's claw";
• Individuals using supplements known to affect polyphenol levels;
• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Interventions

Resveratrol

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Officials

• James Murrough, MD, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and investigators will be masked to whether they are assigned to study supplement or placebo.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a single center, double-blind, placebo-controlled, randomized phase I trial. Each subject will be randomized to a daily low, medium or high dose of BDPP or placebo.

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 9, 2020
• Study Start: January 19, 2021
• Primary Completion: December 2, 2024
• Study Completion: December 2, 2024
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)