drugset / Trial / NCT04421079
Metabolism of Bioactive Dietary Polyphenol Preparation (BDPP)
Phase 1
Completed
84 enrolled
Icahn School of Medicine at Mount Sinai
National Center for Complementary and Integrative Health (NCCIH) · collab
RandomizedParallel-groupQuadruple-blindBasic science
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).
Timeline
- Start
- 2021-01-19
- Primary completion
- 2024-12-02
- Completion
- 2024-12-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Concord grape juice | Other / unclassified | 8 unknown | — |
| Subject | Concord grape juice | Other / unclassified | 16 unknown | — |
| Subject | Concord grape juice | Other / unclassified | 24 unknown | — |
| Subject | Grape seed polyphenol extract | Other / unclassified | 450 mg | — |
| Subject | Grape seed polyphenol extract | Other / unclassified | 900 mg | — |
| Subject | Grape seed polyphenol extract | Other / unclassified | 1200 mg | — |
| Subject | Resveratrol | Small molecule | 150 mg | — |
| Subject | Resveratrol | Small molecule | 300 mg | — |
| Subject | Resveratrol | Small molecule | 450 mg | — |
Indications
No indication recorded.