Cardiovascular Risk FactorsNCT00706888
Study on Effects of a Dairy Product Based on Polyphenols and Enriched With Vitamins B6, B9 and B12 on Some Cardiovascular Factor of Risk
A study testing Vitamins B6, B9 and B12 and polyphenols in people with Cardiovascular Risk Factors, run by Elvir SAS at 1 site in France.
Trial summary
We put forward that polyphenols and vitamins have a cardiovascular prevention effect for subject with cardiovascular risk. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Cardiovascular Risk Factors
- What is being tested?
- Vitamins B6, B9 and B12 and polyphenols
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- Start not givento not given
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI less than 33 kg/m²
- Waist measurement higher than 90 cm for woman and 100 cm for man
- Normal or controled blood pressure (less than 16/9)
- non-smoker
- Female with contraception
Who cannot join
- Food allergy
- Cardiovascular pathology
- Medical treatment for cholesterol
- Higher consumption for dairy product and red fruit
Trial locations and contacts
1 site in 1 country.
About this study
We put forward that polyphenols and vitamins have a cardiovascular prevention effect for subject with cardiovascular risk.
- Conditions
- Cardiovascular Risk Factors
- Being tested
- Vitamins B6, B9 and B12 and polyphenols, placebo
- Keywords
- Reduction of cardiovascular factor of risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamins B6, B9 and B12 and polyphenolsDietary supplement
placeboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Female with active product Receives: Dietary Supplement: Vitamins B6, B9 and B12 and polyphenols |
| 2 | Active comparator | Male with active product Receives: Dietary Supplement: Vitamins B6, B9 and B12 and polyphenols |
| 3 | Placebo comparator | Female with placebo Receives: Dietary Supplement: placebo |
| 4 | Placebo comparator | Male with placebo Receives: Dietary Supplement: placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elvir SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioFortis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00706888
- Sponsor's protocol ID
- Etude 9108
- Status last verified
- Jul 2009
- First submitted
- 26 Jun 2008
- Last updated
- 7 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Effects of a Dairy Product Based on Polyphenols and Enriched With Vitamins B6, B9 and B12 on Some Cardiovascular Factor of Risk
- ClinicalTrials.gov ID
- NCT00706888
- Acronym / sponsor ID
- Etude 9108
- Conditions
- Cardiovascular Risk Factors
- Keywords
- Reduction of cardiovascular factor of risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Elvir SASIndustry (pharma, biotech, devices)
- Collaborators
- BioFortis
- First posted
- 30 Jun 2008 (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.
We put forward that polyphenols and vitamins have a cardiovascular prevention effect for subject with cardiovascular risk.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: Vitamins B6, B9 and B12 and polyphenolsFemale with active product |
| 2 | Active comparator | Dietary Supplement: Vitamins B6, B9 and B12 and polyphenolsMale with active product |
| 3 | Placebo comparator | Dietary Supplement: placeboFemale with placebo |
| 4 | Placebo comparator | Dietary Supplement: placeboMale with placebo |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI less than 33 kg/m²
- Waist measurement higher than 90 cm for woman and 100 cm for man
- Normal or controled blood pressure (less than 16/9)
- non-smoker
- Female with contraception
Key exclusion criteria (4 listed)
- Food allergy
- Cardiovascular pathology
- Medical treatment for cholesterol
- Higher consumption for dairy product and red fruit
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 |
|---|---|---|
| Vitamins B6, B9 and B12 and polyphenols | Dietary supplement | 1, 2 |
| placebo | Dietary supplement | 3, 4 |
Primary outcome
Not reported in the source record.
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 7 Jul 2009.
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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 Vitamins B6, B9 and B12 and polyphenols in people with Cardiovascular Risk Factors, run by Elvir SAS 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 4 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 7 Jul 2009. 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. Some participants in this study may receive a placebo. 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.
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 7 Jul 2009.