- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01400763
Lutein Bioavailability From Fresh and Dried Beverages (METC-11/07)
July 21, 2011 updated by: Wageningen University
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
103
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age 18-35 years
- BMI 18-25 kg/m2
- body weight should be stable for ≥6 months (with no weight gain/loss > 3 kg)
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum lutein concentration
Time Frame: six weeks after intervention
|
six weeks after intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum lipid concentrations
Time Frame: six weeks after intervention
|
six weeks after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
July 20, 2011
First Submitted That Met QC Criteria
July 21, 2011
First Posted (Estimate)
July 22, 2011
Study Record Updates
Last Update Posted (Estimate)
July 22, 2011
Last Update Submitted That Met QC Criteria
July 21, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EYEPOWDER
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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