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Completed

NCT Number: NCT05873530

Circadian Modulation of Grape Consumption and Oxidative Stress Response

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

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Idaho State University

Pocatello, Idaho, 83209, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Grape

Other

Reconstituted whole grape powder

Primary outcomes

  1. Urine F2-isoprostane

    Time frame: baseline

    Oxidative stress marker

  2. Urine F2-isoprostane

    Time frame: hour 1

    Oxidative stress marker

  3. Urine F2-isoprostane

    Time frame: hours 1-6

    Oxidative stress marker

Sponsors and collaborators

Lead sponsor

Idaho State University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
May 24, 2023
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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