Macular PigmentMETC-11/07NCT01400763
Lutein Bioavailability From Fresh and Dried Beverages
A study testing Fresh lutein-enriched egg-yolk beverage, Dried-1 lutein-enriched egg-yolk beverage and Dried-2 lutein-enriched egg-yolk beverage in people with Macular Pigment, run by Wageningen University.
Trial summary
Macular pigment is composed primarily of the xanthophylls lutein and zeaxanthin, which are members of the carotenoid family. Epidemiological evidence indicates that a higher intake of lutein and zeaxanthin is associated with a lower risk to develop age-related macular degeneration (AMD). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Macular Pigment
- What is being tested?
- Fresh lutein-enriched egg-yolk beverage, Dried-1 lutein-enriched egg-yolk beverage and Dried-2 lutein-enriched egg-yolk beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Jul 2011
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18-35 years
- BMI 18-25 kg/m2
- body weight should be stable for ≥6 months (with no weight gain/loss > 3 kg)
Who cannot join
- use of medication except incidental use of pain killers
- pulmonary inhalation medication and except usage of the contraceptive pill
- chronic diseases such as IBD or other stomach or bowel diseases
- not willing to discontinue consumption of vitamin supplements
- allergic to cow milk / dairy products/ eggs/ egg-rich products
- vegetarians
Show all 11Show fewer
- smoking
- pregnant or breastfeeding women
- having donated blood (as blood donor) within 1 month prior to the screening
- visit or planning to do so during the study
- impossible or difficult venapuncture
About this study
Official title: Bioavailability of Lutein From a Lutein-enriched Egg-yolk-beverage and Its Dried Re-suspended Versions.
Macular pigment is composed primarily of the xanthophylls lutein and zeaxanthin, which are members of the carotenoid family. Epidemiological evidence indicates that a higher intake of lutein and zeaxanthin is associated with a lower risk to develop age-related macular degeneration (AMD). The lipid matrix of an egg yolk is an excellent vehicle for the efficient absorption of dietary lutein and it is possible to increase the natural lutein concentration in an egg yolk. A fresh lutein-enriched egg yolk beverage has been produced using these lutein-enriched egg-yolks. However, this beverage has a limited shelf life of maximum three weeks. Drying this fresh beverage extents the shelf live, however, this should be without loosing its functional properties concerning lutein bioavailability. At WUR-FBR two types of drying procedures have been evaluated resulting in two different dried product formulations, which need to be tested. The question is, whether the lutein bioavailability is not affected by different drying procedures.
- Conditions
- Macular Pigment
- Being tested
- Fresh lutein-enriched egg-yolk beverage, Dried-1 lutein-enriched egg-yolk beverage, Dried-2 lutein-enriched egg-yolk beverage, Placebo beverage
- Keywords
- focus of study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh lutein-enriched egg-yolk beverageDietary supplement
Also called NWT-02
Fresh lutein-enriched egg-yolk beverage
Dried-1 lutein-enriched egg-yolk beverageDietary supplement
Dried-1 lutein-enriched egg-yolk beverage
Dried-2 lutein-enriched egg-yolk beverageDietary supplement
Dried-2 lutein-enriched egg-yolk beverage
Placebo beverageDietary supplement
Placebo beverage
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum lutein concentration
Measured: six weeks after intervention
Secondary outcomes (1)
Serum lipid concentrations
Measured: six weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startMay 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular PigmentStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400763
- Sponsor's protocol ID
- EYEPOWDER
- Acronym
- METC-11/07
- Status last verified
- Jul 2011
- First submitted
- 20 Jul 2011
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Lutein From a Lutein-enriched Egg-yolk-beverage and Its Dried Re-suspended Versions.
- ClinicalTrials.gov ID
- NCT01400763
- Acronym / sponsor ID
- METC-11/07 / EYEPOWDER
- Conditions
- Macular Pigment
- Keywords
- focus of study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 22 Jul 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.
Macular pigment is composed primarily of the xanthophylls lutein and zeaxanthin, which are members of the carotenoid family. Epidemiological evidence indicates that a higher intake of lutein and zeaxanthin is associated with a lower risk to develop age-related macular degeneration (AMD). The lipid matrix of an egg yolk is an excellent vehicle for the efficient absorption of dietary lutein and it is possible to increase the natural lutein concentration in an egg yolk. A fresh lutein-enriched egg yolk beverage has been produced using these lutein-enriched egg-yolks. However, this beverage has a limited shelf life of maximum three weeks. Drying this fresh beverage extents the shelf live, however, this should be without loosing its functional properties concerning lutein bioavailability. At WUR-FBR two types of drying procedures have been evaluated resulting in two different dried product formulations, which need to be tested. The question is, whether the lutein bioavailability is not affected by different drying procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age 18-35 years
- BMI 18-25 kg/m2
- body weight should be stable for ≥6 months (with no weight gain/loss > 3 kg)
Key exclusion criteria (11 listed)
- use of medication except incidental use of pain killers
- pulmonary inhalation medication and except usage of the contraceptive pill
- chronic diseases such as IBD or other stomach or bowel diseases
- not willing to discontinue consumption of vitamin supplements
- allergic to cow milk / dairy products/ eggs/ egg-rich products
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 |
|---|---|---|
| Fresh lutein-enriched egg-yolk beverageAlso: NWT-02Fresh lutein-enriched egg-yolk beverage | Dietary supplement | – |
| Dried-1 lutein-enriched egg-yolk beverageDried-1 lutein-enriched egg-yolk beverage | Dietary supplement | – |
| Dried-2 lutein-enriched egg-yolk beverageDried-2 lutein-enriched egg-yolk beverage | Dietary supplement | – |
| Placebo beveragePlacebo beverage | Dietary supplement | – |
Primary outcome
Serum lutein concentration
Time frame: six weeks after intervention
1 secondary outcome
Serum lipid concentrations
Time frame: six weeks after intervention
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 22 Jul 2011.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Fresh lutein-enriched egg-yolk beverage, Dried-1 lutein-enriched egg-yolk beverage and Dried-2 lutein-enriched egg-yolk beverage in people with Macular Pigment, run by Wageningen University.
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 11 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 22 Jul 2011. 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.
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?
Serum lutein concentration (time frame: six weeks after intervention). 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 22 Jul 2011.