Healthy SubjectsFijus RaisolNCT02028936
Study of the Impact of the Regular Consumption of Polyphenol-rich Grape Juice on the Biological Parameters of Oxidative Stress and on Endothelial Function in Healthy Subjects
A study testing Grape juice R@isol and Commercially-available grape juice in people with Healthy Subjects, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Many epidemiological and clinical studies have suggested the negative effect of oxidative stress ( = attack of cell components by free radicals) on the cardiovascular risk, notably in patients with metabolic syndrome, insulin resistance, diabetes or obesity and smokers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Grape juice R@isol and Commercially-available grape juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteFrance
- Study dates
- 24 Oct 2013to 17 Jun 2014
- 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
- Subjects aged from 18 to 50 years
- Men and women
- With national health insurance cover
- With a Body Mass Index between 18.5 and 27.9
- Who have given their written informed consent to take part in the study.
Who cannot join
- Subjects unable to understand the nature and aims of the study and/or those who have difficulty communicating with the investigator.
- Adults under ward of court.
- Those in custody following a decision of the court or the administration.
- Subjects with a risk of a major change in their diet during the trial.
- Those who drink more than 5 cups of tea or coffee a day.
- Those who consumed more than 25 grammes of alcohol a day, every day of the year preceding the inclusion visit.
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- Those who present a history of or current use of psycho-active substances (drugs such as cocain, morphine, heroin...).
- Subjects currently in a period of exclusion relative to another research protocol or for whom the annual cummulation of payments for participation in biomedical research has reached the annual ceiling.
- Presence of any treated chronic disease, and any acute disease within the 4 weeks preceding the inclusion and randomisation visit.
- Persons with diabetes treated with insulin or oral antidiabetics.
- Subjects on lipid-lowering therapy and/or on antioxidants (such as vitamin E, vitamin C, selenium, ß-carotene, Zinc) in the month preceding inclusion.
- Subjects taking multivitamin supplements in the month preceding inclusion.
- Pregnant or breast-feeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Impact of the Regular Consumption of Polyphenol-rich Grape Juice on the Biological Parameters of Oxidative Stress and on Endothelial Function in Healthy Subjects: a Prospective Randomised Double-blind Study
Many epidemiological and clinical studies have suggested the negative effect of oxidative stress ( = attack of cell components by free radicals) on the cardiovascular risk, notably in patients with metabolic syndrome, insulin resistance, diabetes or obesity and smokers.
Polyphenols, notably those present in red grapes, have a certain antioxidant effect. Dietary supplementation with polyphenols in high-risk patients could diminish the harmful consequences of oxidative stress.
The aim of this study is to show that the daily consumption of grape juice rich in polyphenols " R@isol ", has a positive impact on the oxidation/antioxidation balance in healthy volunteers.
- Conditions
- Healthy Subjects
- Being tested
- Grape juice R@isol, Commercially-available grape juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grape juice R@isolOther
Commercially-available grape juiceOther
| Study group | Role | What they receive |
|---|---|---|
| Grape juice rich in polyphenols | Experimental | Not described Receives: Other: Grape juice R@isol |
| grape juice not enriched with polyphenols | Active comparator | Not described Receives: Other: Commercially-available grape juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of plasma levels of hydroxyoctadecadienoic acid
Measured: At inclusion, 15 days and 3 months.
Secondary outcomes (1)
Measurement of endothelial function
Measured: At the inclusion and 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study start24 Oct 2013
- Primary completion17 Jun 2014
- Study completion17 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028936
- Sponsor's protocol ID
- BARDOU FUI 2013
- Acronym
- Fijus Raisol
- Status last verified
- Jan 2019
- First submitted
- 18 Dec 2013
- Last updated
- 10 Jan 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of the Regular Consumption of Polyphenol-rich Grape Juice on the Biological Parameters of Oxidative Stress and on Endothelial Function in Healthy Subjects: a Prospective Randomised Double-blind Study
- ClinicalTrials.gov ID
- NCT02028936
- Acronym / sponsor ID
- Fijus Raisol / BARDOU FUI 2013
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 24 Oct 2013 (actual)
- Primary completion
- 17 Jun 2014 (actual)
- Study completion
- 17 Jun 2014 (actual)
- First posted
- 7 Jan 2014 (estimated)
- 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.
Many epidemiological and clinical studies have suggested the negative effect of oxidative stress ( = attack of cell components by free radicals) on the cardiovascular risk, notably in patients with metabolic syndrome, insulin resistance, diabetes or obesity and smokers.
Polyphenols, notably those present in red grapes, have a certain antioxidant effect. Dietary supplementation with polyphenols in high-risk patients could diminish the harmful consequences of oxidative stress.
The aim of this study is to show that the daily consumption of grape juice rich in polyphenols " R@isol ", has a positive impact on the oxidation/antioxidation balance in healthy volunteers.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grape juice rich in polyphenols | Experimental | Other: Grape juice R@isol |
| grape juice not enriched with polyphenols | Active comparator | Other: Commercially-available grape juice |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects aged from 18 to 50 years
- Men and women
- With national health insurance cover
- With a Body Mass Index between 18.5 and 27.9
- Who have given their written informed consent to take part in the study.
Key exclusion criteria (13 listed)
- Subjects unable to understand the nature and aims of the study and/or those who have difficulty communicating with the investigator.
- Adults under ward of court.
- Those in custody following a decision of the court or the administration.
- Subjects with a risk of a major change in their diet during the trial.
- Those who drink more than 5 cups of tea or coffee a day.
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 |
|---|---|---|
| Grape juice R@isol | Other | Grape juice rich in polyphenols |
| Commercially-available grape juice | Other | grape juice not enriched with polyphenols |
Primary outcome
Measurement of plasma levels of hydroxyoctadecadienoic acid
Time frame: At inclusion, 15 days and 3 months.
1 secondary outcome
Measurement of endothelial function
Time frame: At the inclusion and 3 month
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 10 Jan 2019.
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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 juice R@isol and Commercially-available grape juice in people with Healthy Subjects, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 5 inclusion and 13 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 10 Jan 2019. 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 France. 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?
Measurement of plasma levels of hydroxyoctadecadienoic acid (time frame: At inclusion, 15 days and 3 months.). 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 10 Jan 2019.