Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Wageningen University
ClinicalTrials.gov Identifier:
NCT01400763
First received: July 20, 2011
Last updated: July 21, 2011
Last verified: July 2011
History of Changes
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Bioavailability of Lutein From a Lutein-enriched Egg-yolk-beverage and Its Dried Re-suspended Versions.

Resource links provided by NLM:

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

Further study details as provided by Wageningen University:

Primary Outcome Measures:
  • Serum lutein concentration [ Time Frame: six weeks after intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum lipid concentrations [ Time Frame: six weeks after intervention ] [ Designated as safety issue: Yes ]

Enrollment: 103
Study Start Date: May 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Meike Bunger, Wageningen University and Research Centre
ClinicalTrials.gov Identifier: NCT01400763     History of Changes
Other Study ID Numbers: EYEPOWDER
Study First Received: July 20, 2011
Last Updated: July 21, 2011
Health Authority: The Netherlands:Centrale Commissie Mensgebonden Onderzoek

Keywords provided by Wageningen University:
focus of study

ClinicalTrials.gov processed this record on June 18, 2013