Resveratrol in Healthy Adult Participants

Phase 1

Completed

• Conditions: Healthy, no Evidence of Disease
• Interventions: Drug: resveratrol; Other: pharmacological study; Other: laboratory biomarker analysis

• Registration Number: NCT00721877
• Lead Sponsor: National Cancer Institute (NCI)

Brief 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.

Study Timeline

• Study First Submitted: 2008-07-24
• Study First Submitted QC: 2008-07-24
• Study First Posted: 2008-07-25
• Study Start: 2008-08
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2013-03
• Last Update Submitted: 2014-10-07
• Last Update Posted: 2014-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	pharmacological study	Participants receive oral resveratrol once daily for 4 weeks.
Arm I	laboratory biomarker analysis	Participants receive oral resveratrol once daily for 4 weeks.
Arm I	resveratrol	Participants receive oral resveratrol once daily for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Modulation of CYP enzyme activities	From baseline to end of resveratrol intervention	Will be assessed by a comparison of CYP enzyme activities from baseline to end of resveratrol intervention. CYP1A2, 2D6, 2C9, and 3A4 activity will be assessed by plasma paraxanthine/caffeine ratio, urinary dextromethorphan/dextrophan ratio, urinary losartan/losartan metabolite ratio, and area under the plasma buspirone concentration-time curve, respectively. The primary analysis will consist of paired t-tests of differences in log values from baseline to end of intervention (equivalent to log of the ratio).

Secondary Outcome Measures

Name	Time	Method
Safety evaluation using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0	Up to 6 weeks	Any adverse events will be presented descriptively.
Changes in Phase II enzyme activity	From baseline to end of resveratrol intervention	GST activity and GST-pi level in blood lymphocytes and serum bilirubin levels will be used to assess Phase II enzyme activity. Paired t-tests of differences in values from baseline to end of intervention will be used, with a 2-sided significance level of 0.0167 for the three tests.

Trial Locations

Locations (1)

Arizona Cancer Center - Tucson; 🇺🇸 Tucson, Arizona, United States