Circadian Modulation of Grape Consumption and Oxidative Stress Response

NCT ID: NCT05873530

Last Updated: 2023-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2023-05-01

Brief Summary

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

Detailed Description

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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

Conditions

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Oxidative Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Time

Morning or evening

Group Type EXPERIMENTAL

Grape

Intervention Type OTHER

Reconstituted whole grape powder

Treatment

Grape or Placebo

Group Type EXPERIMENTAL

Grape

Intervention Type OTHER

Reconstituted whole grape powder

Interventions

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Grape

Reconstituted whole grape powder

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Idaho State University

OTHER

Sponsor Role lead

Responsible Party

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Cynthia Blanton

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Idaho State University

Pocatello, Idaho, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-FY2021-264

Identifier Type: -

Identifier Source: org_study_id

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