NCT00721877

Resveratrol in Healthy Adult Participants

Clinical Study of Resveratrol on Drug and Carcinogen Metabolizing Enzymes

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Resveratrol may prevent cancer in healthy people. Studying samples of blood and urine in the laboratory from participants who are taking resveratrol may help doctors learn more about how this drug is used by the body. This phase I trial is studying the side effects of resveratrol and to see how it works in healthy adult participants.

Detailed description

PRIMARY OBJECTIVES: I. To determine the effect of resveratrol on human cytochrome P450 (CYP) enzyme activity in healthy adult participants. SECONDARY OBJECTIVES: I. To determine the modulation effect on phase II detoxification enzymes. II. To evaluate safety in participants treated with this drug. OUTLINE: Participants receive oral resveratrol once daily for 4 weeks. Patients complete a daily diary documenting adverse events and an intake calendar for recording the daily intake of any non-routine medications. Participants undergo blood sample collection periodically. Lymphocytes are isolated and analyzed for baseline GST activity and level. Serum is analyzed to determine bilirubin levels to be used as surrogate UGT 1A1 activity. Analyses of CYP probe drugs will be performed using high performance liquid chromatography (HPLC) assays. A sensitive ELISA assay will be used for quantitative analyses. Urine samples are collected periodically and drug and metabolite levels will be analyzed. After completion of study treatment, participants are followed for 2 weeks.

Conditions

• Healthy, no Evidence of Disease

Interventions

Type	Name	Description
DRUG	resveratrol	Given orally
OTHER	pharmacological study	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2008-07-25
• Last updated: 2014-10-08

Locations

1 site across 1 country: United States