Healthy VolunteersPhase 1FLORIDENCT00983086
Effects of Consumption of Orange Juice on Vascular Protection and Immune Function: Clinical Study on the Specific Contribution of Citrus Flavanones
A Phase 1 study testing Flavanones of orange juice in people with Healthy Volunteers, run by University Hospital, Clermont-Ferrand.
Trial summary
Epidemiological studies have firmly established the health effects of high intakes of fruits and vegetables and in particular in regards to the prevention of cardiovascular diseases. Citrus fruits are the most widely consumed throughout the world, mainly as juice. Read more about this study
- Who is it for?
- Ages 50 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Flavanones of orange juice
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Apr 2008
- Phase
- Phase 1
- 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 50 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males
- Age: 50 to 65 inclusive
- Body mass index of 25 to 30 kg / m² (inclusive
Who cannot join
- Hypertriglyceridemia or known hypercholesterolemia, treated or not
- Serology HIV and / or HCV positive
About this study
Epidemiological studies have firmly established the health effects of high intakes of fruits and vegetables and in particular in regards to the prevention of cardiovascular diseases. Citrus fruits are the most widely consumed throughout the world, mainly as juice. Citrus fruits are rich in vitamin C but also in various plant micronutrients which are the most abundant polyphenols. Several in vitro studies and animal models suggest that the polyphenols of citrus are involved in the protective effects of citrus vis-à-vis the cardiovascular diseases. However, profits in health associated with taking these polyphenols are unknown and so far no clinical studies have been conducted to determine the contribution of polyphenols of citrus in this protection.
The main objectives of this project are (1) to characterize the effects of single dose and made repeated consumption of orange juice on vascular protection and the immune response and (2) to assess the specific role of polyphenols present in citrus fruits in this protection. To do this the investigators will conduct a clinical study, randomized and crossover, among healthy men 50 to 65 years that are slightly overweight. These volunteers, who continue to follow their usual diet, should consume daily for 4 weeks (1) orange juice or (2) an isocaloric control beverage or (3) the same drink spiked with a dose of polyphenols similar to that given by orange juice.
Read the detailed description
Clinical study, randomized, crossover, double-blind in healthy men 50 to 65 years who are slightly overweight.
- Conditions
- Healthy Volunteers
- Being tested
- Flavanones of orange juice
- Keywords
- Flavanones and vascular function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flavanones of orange juiceDrug
The main objective of this study is to evaluate, in healthy volunteers with young children (50 and 65) and slightly overweight according to their usual diet, the effects of single dose (in postprandial period) and made repeated orange juice or orange flavanones purified on vascular function. The selection criteria for age and weight should, within a healthy population to select individuals who exhibit cardiovascular risk factors, and thus for which it should be a priori easier to identify a beneficial effect of dietary factors on the parameters associated with cardiovascular risk.
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the effects of repeated consumption of orange juice or purified flavanones in immune function
Measured: after consumption of orange juice
Secondary outcomes (2)
Measuring the impact of consumption of orange juice or purified flavanones on acid-base balance
Measured: after consumption of orange juice
Evaluate the effects of chronic consumption of orange juice or purified flavanones on gene expression by a global transcriptomic approach in mononuclear cells from peripheral blood
Measured: after consumption of orange juice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study startAug 2007
- Primary completionFeb 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Investigators
- Claude Dubray, PU PH, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00983086
- Sponsor's protocol ID
- CHU-0059
- Acronym
- FLORIDE
- Status last verified
- Sep 2009
- First submitted
- 22 Sep 2009
- Last updated
- 23 Sep 2009
- Results posted
- No
Publications
Milenkovic D, Deval C, Dubray C, Mazur A, Morand C. Hesperidin displays relevant role in the nutrigenomic effect of orange juice on blood leukocytes in human volunteers: a randomized controlled cross-over study. PLoS One. 2011;6(11):e26669. doi: 10.1371/journal.pone.0026669. Epub 2011 Nov 16.
PubMed 22110589Morand C, Dubray C, Milenkovic D, Lioger D, Martin JF, Scalbert A, Mazur A. Hesperidin contributes to the vascular protective effects of orange juice: a randomized crossover study in healthy volunteers. Am J Clin Nutr. 2011 Jan;93(1):73-80. doi: 10.3945/ajcn.110.004945. Epub 2010 Nov 10.
PubMed 21068346
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Consumption of Orange Juice on Vascular Protection and Immune Function: Clinical Study on the Specific Contribution of Citrus Flavanones
- ClinicalTrials.gov ID
- NCT00983086
- Acronym / sponsor ID
- FLORIDE / CHU-0059
- Conditions
- Healthy Volunteers
- Keywords
- Flavanones and vascular function
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Study start
- Aug 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 23 Sep 2009 (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.
Epidemiological studies have firmly established the health effects of high intakes of fruits and vegetables and in particular in regards to the prevention of cardiovascular diseases. Citrus fruits are the most widely consumed throughout the world, mainly as juice. Citrus fruits are rich in vitamin C but also in various plant micronutrients which are the most abundant polyphenols. Several in vitro studies and animal models suggest that the polyphenols of citrus are involved in the protective effects of citrus vis-à-vis the cardiovascular diseases. However, profits in health associated with taking these polyphenols are unknown and so far no clinical studies have been conducted to determine the contribution of polyphenols of citrus in this protection.
The main objectives of this project are (1) to characterize the effects of single dose and made repeated consumption of orange juice on vascular protection and the immune response and (2) to assess the specific role of polyphenols present in citrus fruits in this protection. To do this the investigators will conduct a clinical study, randomized and crossover, among healthy men 50 to 65 years that are slightly overweight. These volunteers, who continue to follow their usual diet, should consume daily for 4 weeks (1) orange juice or (2) an isocaloric control beverage or (3) the same drink spiked with a dose of polyphenols similar to that given by orange juice.
Detailed description
Clinical study, randomized, crossover, double-blind in healthy men 50 to 65 years who are slightly overweight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males
- Age: 50 to 65 inclusive
- Body mass index of 25 to 30 kg / m² (inclusive
Key exclusion criteria (2 listed)
- Hypertriglyceridemia or known hypercholesterolemia, treated or not
- Serology HIV and / or HCV positive
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 |
|---|---|---|
| Flavanones of orange juiceThe main objective of this study is to evaluate, in healthy volunteers with young children (50 and 65) and slightly overweight according to their usual diet, the effects of single dose (in postprandial period) and made repeated orange juice or orange flavanones purified on vascular function. The selection criteria for age and weight should, within a healthy population to select individuals who exhibit cardiovascular risk factors, and thus for which it should be a priori easier to identify a beneficial effect of dietary factors on the parameters associated with cardiovascular risk. | Drug | – |
Primary outcome
Determine the effects of repeated consumption of orange juice or purified flavanones in immune function
Time frame: after consumption of orange juice
2 secondary outcomes
Measuring the impact of consumption of orange juice or purified flavanones on acid-base balance
Time frame: after consumption of orange juice
Evaluate the effects of chronic consumption of orange juice or purified flavanones on gene expression by a global transcriptomic approach in mononuclear cells from peripheral blood
Time frame: after consumption of orange juice
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 23 Sep 2009.
- Derived from this study: PubMed 22110589Milenkovic D, Deval C, Dubray C, Mazur A, Morand C. Hesperidin displays relevant role in the nutrigenomic effect of orange juice on blood leukocytes in human volunteers: a randomized controlled cross-over study. PLoS One. 2011;6(11):e26669. doi: 10.1371/journal.pone.0026669. Epub 2011 Nov 16.
- Derived from this study: PubMed 21068346Morand C, Dubray C, Milenkovic D, Lioger D, Martin JF, Scalbert A, Mazur A. Hesperidin contributes to the vascular protective effects of orange juice: a randomized crossover study in healthy volunteers. Am J Clin Nutr. 2011 Jan;93(1):73-80. doi: 10.3945/ajcn.110.004945. Epub 2010 Nov 10.
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Pain
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.
Claude Dubray, PU PH principal investigator
University Hospital, Clermont-Ferrand
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Flavanones of orange juice in people with Healthy Volunteers, run by University Hospital, Clermont-Ferrand.
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 3 inclusion and 2 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 23 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Determine the effects of repeated consumption of orange juice or purified flavanones in immune function (time frame: after consumption of orange juice). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00983086, which also lists 2 linked publications.
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 23 Sep 2009.