NCT05873530

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2022

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

8 months

First QC Date

May 15, 2023

Last Update Submit

May 23, 2023

Conditions

Oxidative Stress

Outcome Measures

Primary Outcomes (3)

  • Urine F2-isoprostane

    Oxidative stress marker

    baseline

  • Urine F2-isoprostane

    Oxidative stress marker

    hour 1

  • Urine F2-isoprostane

    Oxidative stress marker

    hours 1-6

Study Arms (2)

Time

EXPERIMENTAL

Morning or evening

Other: Grape

Treatment

EXPERIMENTAL

Grape or Placebo

Other: Grape

Interventions

GrapeOTHER

Reconstituted whole grape powder

TimeTreatment

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Age 18-50 y

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Idaho State University

Pocatello, Idaho, 83209, United States

Location

MeSH Terms

Interventions

whole grape extract

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 15, 2023

First Posted

May 24, 2023

Study Start

September 1, 2021

Primary Completion

May 12, 2022

Study Completion

May 1, 2023

Last Updated

May 24, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)