Circadian Modulation of Grape Consumption and Oxidative Stress Response

May 23, 2023 updated by: Cynthia Blanton, Idaho State University
This study investigated the effects of time-of-day of grape consumption on high-fat meal-induced oxidative stress.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Idaho
      • Pocatello, Idaho, United States, 83209
        • Idaho State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Time
Morning or evening
Other: Grape
Reconstituted whole grape powder
Experimental: Treatment
Grape or Placebo
Other: Grape
Reconstituted whole grape powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urine F2-isoprostane
Time Frame: baseline
Oxidative stress marker
baseline
Urine F2-isoprostane
Time Frame: hour 1
Oxidative stress marker
hour 1
Urine F2-isoprostane
Time Frame: hours 1-6
Oxidative stress marker
hours 1-6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Idaho State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

May 12, 2022

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

May 15, 2023

First Submitted That Met QC Criteria

May 23, 2023

First Posted (Actual)

May 24, 2023

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • IRB-FY2021-264

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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