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NCT04421079 · ClinicalTrials.gov registry record · Phase 1

Metabolism of Bioactive Dietary Polyphenol Preparation (BDPP)

A Phase 1 study of Healthy Control, sponsored by Icahn School of Medicine at Mount Sinai.

Completed
Registry status
Phase 1
Development phase
84
Enrollment target
1
Study location

NCT04421079 is a Phase 1 study of Healthy Control that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 84 participants, below the 298-participant average among 6 other Healthy Control trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04421079, a Phase 1 study of Healthy Control, has completed, sponsored by Icahn School of Medicine at Mount Sinai.

COMPLETED
Registry status
Phase 1
Development phase
84 participants
Enrollment target
1
Study location

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 Studied

Healthy Control

Interventions

  • DRUG Placebo
  • DIETARY_SUPPLEMENT Trans-resveratrol
  • DIETARY_SUPPLEMENT Concord grape juice
  • DIETARY_SUPPLEMENT Grape seed polyphenol extract

Study Locations (1)

New York

  • Icahn School of Medicine at Mount Sinai - New York

Trial Details

FieldValue
Enrollment Target 84 participants
Start Date 2021-01-19
Est. Completion 2024-12-02
Phase Phase 1

Sponsor

Icahn School of Medicine at Mount Sinai

708 total trials

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What the Registry Record Tells You About NCT04421079

The ClinicalTrials.gov registry entry for NCT04421079 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 298-participant average among 6 other Healthy Control trials with a reported enrollment target (72% lower). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy Control appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.

NCT04421079 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT04421079 about?

NCT04421079 is a clinical study titled "Metabolism of Bioactive Dietary Polyphenol Preparation (BDPP)". 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).

What is the current status of trial NCT04421079?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 84 participants. The study started on 2021-01-19. Estimated completion is 2024-12-02.

What conditions does trial NCT04421079 study?

This clinical trial studies the following conditions: Healthy Control.

What interventions are being tested in trial NCT04421079?

The interventions under investigation include: Placebo (DRUG), Trans-resveratrol (DIETARY_SUPPLEMENT), Concord grape juice (DIETARY_SUPPLEMENT), Grape seed polyphenol extract (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT04421079?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04421079 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.