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OpenTrials
Completed

NCT Number: NCT01400763

Lutein Bioavailability From Fresh and Dried Beverages

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.

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Key information

Conditions

Macular Pigment

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fresh lutein-enriched egg-yolk beverage

Dietary Supplement

Fresh lutein-enriched egg-yolk beverage

Other names: NWT-02

Dried-1 lutein-enriched egg-yolk beverage

Dietary Supplement

Dried-1 lutein-enriched egg-yolk beverage

Dried-2 lutein-enriched egg-yolk beverage

Dietary Supplement

Dried-2 lutein-enriched egg-yolk beverage

Placebo Beverage

Dietary Supplement

Placebo beverage

Primary outcomes

  1. Serum lutein concentration

    Time frame: six weeks after intervention

Secondary outcomes

  1. Serum lipid concentrations

    Time frame: six weeks after intervention

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Registry information

Official study title

Bioavailability of Lutein From a Lutein-enriched Egg-yolk-beverage and Its Dried Re-suspended Versions.

Acronym: METC-11/07

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 22, 2011
Registry last updated
Jul 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.