Lutein Bioavailability From Fresh and Dried Beverages

Macular Pigment Clinical Trial

— METC-11/07  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01400763
• Other study ID #: EYEPOWDER
• Status: Completed
• Phase: N/A
• First received: July 20, 2011
• Last updated: July 21, 2011
• Start date: May 2011
• Est. completion date: July 2011

Study information

• Verified date: July 2011
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: The Netherlands:Centrale Commissie Mensgebonden Onderzoek
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Macular Pigment

Intervention

Dietary Supplement:
• Fresh lutein-enriched egg-yolk beverage
Fresh lutein-enriched egg-yolk beverage
• Dried-1 lutein-enriched egg-yolk beverage
Dried-1 lutein-enriched egg-yolk beverage
• Dried-2 lutein-enriched egg-yolk beverage
Dried-2 lutein-enriched egg-yolk beverage
• Placebo beverage
Placebo beverage

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wageningen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum lutein concentration		six weeks after intervention	No
Secondary	Serum lipid concentrations		six weeks after intervention	Yes