Macular Pigment Optical DensityPhase 4NCT00449917
"Visiobiane Anti-age" Effects on Vision Parameters
A Phase 4 study testing lutein, DHA and vitamins in people with Macular Pigment Optical Density, run by PiLeJe at 1 site in France.
Trial summary
The purpose of this study is to determine the benefits of "Visiobiane Anti-age" dietary supplement on macular pigment optical density, contrast sensibility and visual acuity. Additionally, the study would like to evaluate seric variations of carotenoids and the total antioxydant capacity. Read more about this study
- Who is it for?
- Ages 45 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Macular Pigment Optical Density
- What is being tested?
- lutein, DHA and vitamins
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2006to Nov 2007
- Phase
- Phase 4
- 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 45 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy caucasian men
- age : 45-55
- BMI < 25
Who cannot join
- non healthy
- retinian and/or visual anomaly
- Ocular media not clear enough to allow good fundus photography
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Effects of "Visiobiane Anti-age" Dietary Supplement on Macular Pigment Optical Density, Contrast Sensibility and Visual Acuity
The purpose of this study is to determine the benefits of "Visiobiane Anti-age" dietary supplement on macular pigment optical density, contrast sensibility and visual acuity. Additionally, the study would like to evaluate seric variations of carotenoids and the total antioxydant capacity.
Read the detailed description
Visiobiane study is a randomized trial of 30 participants designed to assess the effects of oral supplementation of macular xanthophylls (lutein and zeaxanthin) and omega-3 LCPUFAs for the eyes protection. The study will enroll healthy participants aged 45 to 55 years. 15 subjects will be assigned in placebo group and 15 in experimetal group (Visiobiane anti-age). They will be supplemented for 24 weeks
- Conditions
- Macular Pigment Optical Density
- Being tested
- lutein, DHA, vitamins
- Keywords
- visual caracteristics, macular pigment optical density, visual acuity, contrast sensibility, lutein, docosahexaenoic acid (DHA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
luteinDrug
DHADrug
vitaminsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
macular pigment optical density
Secondary outcomes (5)
contrast sensibility
visual acuity
seric carotenoids concentrations
total antioxidant capacity
influence of SR-B1 genetic polimorphism
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2007 (estimated)
- Study startSep 2006
- Primary completionJul 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular Pigment Optical DensityStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- PiLeJe
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Franck Bacin, MD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449917
- Sponsor's protocol ID
- P11
- Status last verified
- Oct 2011
- First submitted
- 20 Mar 2007
- Last updated
- 6 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effects of "Visiobiane Anti-age" Dietary Supplement on Macular Pigment Optical Density, Contrast Sensibility and Visual Acuity
- ClinicalTrials.gov ID
- NCT00449917
- Acronym / sponsor ID
- P11
- Conditions
- Macular Pigment Optical Density
- Keywords
- visual caracteristics, macular pigment optical density, visual acuity, contrast sensibility, lutein, docosahexaenoic acid (DHA)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- PiLeJeIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 21 Mar 2007 (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.
The purpose of this study is to determine the benefits of "Visiobiane Anti-age" dietary supplement on macular pigment optical density, contrast sensibility and visual acuity. Additionally, the study would like to evaluate seric variations of carotenoids and the total antioxydant capacity.
Detailed description
Visiobiane study is a randomized trial of 30 participants designed to assess the effects of oral supplementation of macular xanthophylls (lutein and zeaxanthin) and omega-3 LCPUFAs for the eyes protection. The study will enroll healthy participants aged 45 to 55 years. 15 subjects will be assigned in placebo group and 15 in experimetal group (Visiobiane anti-age). They will be supplemented for 24 weeks
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy caucasian men
- age : 45-55
- BMI < 25
Key exclusion criteria (3 listed)
- non healthy
- retinian and/or visual anomaly
- Ocular media not clear enough to allow good fundus photography
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 |
|---|---|---|
| lutein | Drug | – |
| DHA | Drug | – |
| vitamins | Drug | – |
Primary outcome
macular pigment optical density
5 secondary outcomes
contrast sensibility
visual acuity
seric carotenoids concentrations
total antioxidant capacity
influence of SR-B1 genetic polimorphism
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 6 Oct 2011.
Related trials for Macular Pigment Optical Density
Recruiting
Lutein, Zeaxathin, and Fish Oil Supplementation
Cognitive Performance, Age-Related Macular Degeneration
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.
Franck Bacin, MD principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lutein, DHA and vitamins in people with Macular Pigment Optical Density, run by PiLeJe 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 3 inclusion and 3 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 6 Oct 2011. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
macular pigment optical density. 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 6 Oct 2011.