Ignite Creation Date:
2025-12-18 @ 7:41 AM
Ignite Modification Date:
2025-12-23 @ 10:36 PM
Study NCT ID:
NCT00721877
Status:
None
Last Update Posted:
2014-10-08 00:00:00
First Post:
2008-07-24 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Resveratrol in Healthy Adult Participants
Sponsor:
None
Organization:
Study Overview
Official Title:
Clinical Study of Resveratrol on Drug and Carcinogen Metabolizing Enzymes
Status:
None
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: