Lutein Bioavailability From Fresh and Dried Beverages

NCT01400763 | Completed DMC

• 1 other identifier: EYEPOWDER
• Study Type: interventional
• Target: 103
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Macular Pigment

Keywords

focus of study

Outcome Measures

Primary Outcomes (1)

• Serum lutein concentration

  six weeks after intervention

Secondary Outcomes (1)

• Serum lipid concentrations

  six weeks after intervention

Interventions

Fresh lutein-enriched egg-yolk beverage DIETARY_SUPPLEMENT

Fresh lutein-enriched egg-yolk beverage

Also known as: 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

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age 18-35 years
• BMI 18-25 kg/m2
• body weight should be stable for ≥6 months (with no weight gain/loss \> 3 kg)

You may not qualify if:

• 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

Sponsors & Collaborators

• Wageningen University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 20, 2011
• First Posted: July 22, 2011
• Study Start: May 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 22, 2011

Record last verified: 2011-07