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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01400763
Recruitment Status : Completed
First Posted : July 22, 2011
Last Update Posted : July 22, 2011
Information provided by:
Wageningen University

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
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 2011
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Lutein
U.S. FDA Resources

Intervention Details:
    Dietary Supplement: Fresh lutein-enriched egg-yolk beverage
    Fresh lutein-enriched egg-yolk beverage
    Other Name: NWT-02
    Dietary Supplement: Dried-1 lutein-enriched egg-yolk beverage
    Dried-1 lutein-enriched egg-yolk beverage
    Dietary Supplement: Dried-2 lutein-enriched egg-yolk beverage
    Dried-2 lutein-enriched egg-yolk beverage
    Dietary Supplement: Placebo beverage
    Placebo beverage

Primary Outcome Measures :
  1. Serum lutein concentration [ Time Frame: six weeks after intervention ]

Secondary Outcome Measures :
  1. Serum lipid concentrations [ Time Frame: six weeks after intervention ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
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

Responsible Party: Meike Bunger, Wageningen University and Research Centre Identifier: NCT01400763     History of Changes
Other Study ID Numbers: EYEPOWDER
First Posted: July 22, 2011    Key Record Dates
Last Update Posted: July 22, 2011
Last Verified: July 2011

Keywords provided by Wageningen University:
focus of study