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NCT05873530 Clinical Trial

Circadian Modulation of Grape Consumption and Oxidative Stress Response

Oxidative Stress Clinical Trial

Official title:
Circadian Modulation of Grape Consumption and Oxidative Stress Response

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05873530
Other study ID # IRB-FY2021-264
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date May 1, 2023

Study information
Verified date May 2023
Source Idaho State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study investigated the effects of time-of-day of grape consumption on high-fat meal-induced oxidative stress.

Description:

Grape consumption acts on the immune system to produce antioxidant and anti-inflammatory effects. Since immune activity demonstrates circadian rhythmicity, with peak activity occurring during waking hours, the timing of grape intake may influence the magnitude of its antioxidant effect. This study followed a 2 x 2 factorial randomized, controlled design wherein healthy men and women (n = 32) consumed either a grape or placebo drink with a high-fat meal in the morning or evening. Urine was collected for measurements of biomarkers of oxidative stress and grape metabolites at baseline and post-meal at hour 1 and hours 1-6

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date May 1, 2023
Est. primary completion date May 12, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Healthy - Age 18-50 y Exclusion Criteria: - Employed in shift or night work - Extreme early or late chronotype - Presence of acute infection or chronic inflammatory disease - Smoking - Heavy aerobic exerciser - Greater than moderate alcohol intake - Pregnancy or lactation - Use of non-steroidal anti-inflammatory medications or antioxidant dietary supplements.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Grape
Reconstituted whole grape powder

Locations
Country Name City State
United States Idaho State University Pocatello Idaho

Sponsors (1)
Lead Sponsor Collaborator
Idaho State University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Urine F2-isoprostane Oxidative stress marker baseline
Primary Urine F2-isoprostane Oxidative stress marker hour 1
Primary Urine F2-isoprostane Oxidative stress marker hours 1-6
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