METC-11/07: Lutein Bioavailability From Fresh and Dried Beverages

• Sponsor: Wageningen University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01400763
• Collaborator: (none)
• Enrollment: 103
• Duration (Months): 2

Study Details

Study Description

Brief 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). 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.

Condition or Disease	Intervention/Treatment	Phase
Macular Pigment	Dietary Supplement: Fresh lutein-enriched egg-yolk beverage; Dietary Supplement: Dried-1 lutein-enriched egg-yolk beverage; Dietary Supplement: Dried-2 lutein-enriched egg-yolk beverage; Dietary Supplement: Placebo beverage	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 103 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: Bioavailability of Lutein From a Lutein-enriched Egg-yolk-beverage and Its Dried Re-suspended Versions.
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Jul 1, 2011

Outcome Measures

Primary Outcome Measures

1. Serum lutein concentration [six weeks after intervention]

Secondary Outcome Measures

1. Serum lipid concentrations [six weeks after intervention]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Wageningen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01400763
• Other Study ID Numbers: EYEPOWDER
• First Posted: Jul 22, 2011
• Last Update Posted: Jul 22, 2011
• Last Verified: Jul 1, 2011

• Keywords provided by , ,: focus of study

Study Results

No Results Posted as of Jul 22, 2011