Age-related Macular DegenerationALGOVUENCT01480700
Consumption of Eggs Rich in Lutein and Omega-3 Fatty Acids on the Macular Pigment
A study testing Nutritional study in people with Age-related Macular Degeneration, run by Institut Pasteur de Lille at 1 site in France.
Trial summary
This study is to determine the impact of the consumption of eggs rich in lutein/zeaxanthin from lucerne protein concentrate and DHA from microalgae on the plasma levels of these compounds but also on the macular pigment optical density, whose elevation may be beneficial in the prevention of Age-related Macular… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-related Macular Degeneration
- What is being tested?
- Nutritional study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2011to Feb 2013
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy subjects (male or female),
- 18 to 55 years
- Having signed the consent form,
- Susceptible to accept the stresses generated by the study,
- Insured.
Who cannot join
- Corrected Visual Acuity <8/10th,
- History of cardiovascular disease, specifically coronary heart disease,
- Characterized dyslipidemia
- Total cholesterol ³ 2.50 g / L, and / or triglycerides ³ 2.00 g / L
- Lipid-lowering treatment,
- Current smoking or person who stopped smoking less than 6 months
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- Cataract or cataract surgery,
- Diabetes
- Body Mass Index (BMI)> 30 kg/m2,
- Taking food supplements in the 3 months preceding the start of the study (carotenoids, omega-3 fatty acids, phytosterols),
- Regular consumption in the three months preceding the start of the study products with added phytosterols.
- Regular consumption of high fatty fish or shellfish rich in omega-3 (4x a week or more): salmon, sardines, mackerel, herring, trout, tuna, red mullet, sea bass, bream, farmed turbot, mussels, squid / squid, anchovies.
- Allergy to eggs
- Dieting
- Difference significant weight over the last 3 months (> 3 kg)
- Inability to understand or adhere to the protocol
- Persons deprived of liberty
- People in a position to judicial protection
- Pregnant Women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Consumption of Eggs Rich in Xanthophyll Carotenoids and Omega-3 Fatty Acids on the Macular Pigment in Healthy People
This study is to determine the impact of the consumption of eggs rich in lutein/zeaxanthin from lucerne protein concentrate and DHA from microalgae on the plasma levels of these compounds but also on the macular pigment optical density, whose elevation may be beneficial in the prevention of Age-related Macular Degeneration (AMD).
- Conditions
- Age-related Macular Degeneration
- Being tested
- Nutritional study
- Keywords
- eggs, Optical Macular Pigment, Age Macular Degeneration, study for the Age Macular Degeneration prevention
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional studyOther
subjects consume 2 eggs per day during 4 months
| Study group | Role | What they receive |
|---|---|---|
| rich-eggs | Experimental | subjects consume 2 eggs rich in lutein/zeaxanthin and DHA per day during 4 months Receives: Other: Nutritional study |
| standard eggs | Active comparator | subjects consume 2 standard eggs per day Receives: Other: Nutritional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in optical density of macular pigment after 4 months of eggs consumption
optical density of macular pigment was measured with a Heidelberg Retinal Angiograph (HRA)specially modify for the measure of the pigment.
Measured: before the eggs consumption and four months afterwards
Secondary outcomes (2)
change from baseline in lutein and zeaxanthin in plasma and lipoproteins after 4 months of egg consumption
lutein and zeaxanthin were measured by HPLC
Measured: before the eggs consumption and four months afterwards
change from baseline in fatty acids in plasma and lipoproteins after 4 months of egg consumption
Fatty acids were measured by Gas Chromatography.
Measured: before the eggs consumption and four months afterwards
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Macular DegenerationStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur de Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Roquette Freres, Sanders
- Responsible party
- Principal investigator, Jean-Michel Lecerf, Institut Pasteur de Lille
- Investigators
- Jean-Michel Lecerf, MD, Principal investigator, Institut Pasteur de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480700
- Sponsor's protocol ID
- 2011-A00364-37
- Acronym
- ALGOVUE
- Status last verified
- Aug 2013
- First submitted
- 13 Sep 2011
- Last updated
- 5 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Consumption of Eggs Rich in Xanthophyll Carotenoids and Omega-3 Fatty Acids on the Macular Pigment in Healthy People
- ClinicalTrials.gov ID
- NCT01480700
- Acronym / sponsor ID
- ALGOVUE / 2011-A00364-37
- Conditions
- Age-related Macular Degeneration
- Keywords
- eggs, Optical Macular Pigment, Age Macular Degeneration, study for the Age Macular Degeneration prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Institut Pasteur de LilleUniversity, hospital or other
- Collaborators
- Roquette Freres, Sanders
- Study start
- Oct 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 29 Nov 2011 (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.
This study is to determine the impact of the consumption of eggs rich in lutein/zeaxanthin from lucerne protein concentrate and DHA from microalgae on the plasma levels of these compounds but also on the macular pigment optical density, whose elevation may be beneficial in the prevention of Age-related Macular Degeneration (AMD).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rich-eggs | Experimental | Other: Nutritional studysubjects consume 2 eggs rich in lutein/zeaxanthin and DHA per day during 4 months |
| standard eggs | Active comparator | Other: Nutritional studysubjects consume 2 standard eggs per day |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- healthy subjects (male or female),
- 18 to 55 years
- Having signed the consent form,
- Susceptible to accept the stresses generated by the study,
- Insured.
Key exclusion criteria (19 listed)
- Corrected Visual Acuity <8/10th,
- History of cardiovascular disease, specifically coronary heart disease,
- Characterized dyslipidemia
- Lipid-lowering treatment,
- Current smoking or person who stopped smoking less than 6 months
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 |
|---|---|---|
| Nutritional studysubjects consume 2 eggs per day during 4 months | Other | rich-eggs, standard eggs |
Primary outcome
change from baseline in optical density of macular pigment after 4 months of eggs consumption
Time frame: before the eggs consumption and four months afterwards
optical density of macular pigment was measured with a Heidelberg Retinal Angiograph (HRA)specially modify for the measure of the pigment.
2 secondary outcomes
change from baseline in lutein and zeaxanthin in plasma and lipoproteins after 4 months of egg consumption
Time frame: before the eggs consumption and four months afterwards
change from baseline in fatty acids in plasma and lipoproteins after 4 months of egg consumption
Time frame: before the eggs consumption and four months afterwards
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 5 Aug 2013.
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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.
Jean-Michel Lecerf, MD principal investigator
Institut Pasteur de Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional study in people with Age-related Macular Degeneration, run by Institut Pasteur de Lille 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 19 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 5 Aug 2013. 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?
change from baseline in optical density of macular pigment after 4 months of eggs consumption (time frame: before the eggs consumption and four months afterwards). 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 5 Aug 2013.