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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: Completed Phase 1 study of Healthy Control, sponsored by Icahn School of Medicine at Mount Sinai.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Bioavailability assessed to show a dose-dependent increase in key BDPP metabolites, including DHCA.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2021-01-19 |
| Est. Completion | 2024-12-02 |
| Phase | Phase 1 |
What the finished NCT04421079 record still lists
NCT04421079 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 298-participant average among 6 other Healthy Control trials with a reported enrollment target (72% lower).
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 a single indexed study location in 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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