Oxidative StressNCT05873530
Circadian Modulation of Grape Consumption and Oxidative Stress Response
A study testing Grape in people with Oxidative Stress, run by Idaho State University at 1 site in United States.
Trial summary
This study investigated the effects of time-of-day of grape consumption on high-fat meal-induced oxidative stress. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress
- What is being tested?
- Grape
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 1 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Age 18-50 y
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
This study investigated the effects of time-of-day of grape consumption on high-fat meal-induced oxidative stress.
Read the 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
- Conditions
- Oxidative Stress
- Being tested
- Grape
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GrapeOther
Reconstituted whole grape powder
| Study group | Role | What they receive |
|---|---|---|
| Time | Experimental | Morning or evening Receives: Other: Grape |
| Treatment | Experimental | Grape or Placebo Receives: Other: Grape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine F2-isoprostane
Oxidative stress marker
Measured: baseline
Urine F2-isoprostane
Oxidative stress marker
Measured: hour 1
Urine F2-isoprostane
Oxidative stress marker
Measured: hours 1-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start1 Sep 2021
- Primary completion12 May 2022
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idaho State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cynthia Blanton, Idaho State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05873530
- Sponsor's protocol ID
- IRB-FY2021-264
- Status last verified
- May 2023
- First submitted
- 15 May 2023
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circadian Modulation of Grape Consumption and Oxidative Stress Response
- ClinicalTrials.gov ID
- NCT05873530
- Acronym / sponsor ID
- IRB-FY2021-264
- Conditions
- Oxidative Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Idaho State UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 12 May 2022 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigated the effects of time-of-day of grape consumption on high-fat meal-induced oxidative stress.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time | Experimental | Other: GrapeMorning or evening |
| Treatment | Experimental | Other: GrapeGrape or Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy
- Age 18-50 y
Key exclusion criteria (8 listed)
- Employed in shift or night work
- Extreme early or late chronotype
- Presence of acute infection or chronic inflammatory disease
- Smoking
- Heavy aerobic exerciser
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GrapeReconstituted whole grape powder | Other | Time, Treatment |
Primary outcome
Urine F2-isoprostane
Time frame: baseline
Oxidative stress marker
Urine F2-isoprostane
Time frame: hour 1
Oxidative stress marker
Urine F2-isoprostane
Time frame: hours 1-6
Oxidative stress marker
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grape in people with Oxidative Stress, run by Idaho State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine F2-isoprostane (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.