Effects of Xanthophylls on Optical Density

Age-Related Macular Degeneration Clinical Trial

Official title:

Alteration of Optical Density and Plasma Xanthophylls After Short Term Supplementation With Macular Carotenoids in Patients With AMD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01316198
• Other study ID #: BioPlant-LZ-AMD2011
• Status: Completed
• Phase: N/A
• First received: March 15, 2011
• Last updated: July 26, 2012
• Start date: June 2010
• Est. completion date: July 2011

Study information

• Verified date: July 2012
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The objective of the study was to investigate the influence of a intervention with lutein und zeaxanthin from crucifers on the optical density of the macular pigment of patients with non exudative age-related maculopathy. It is hypothesized that the applied study beverage elevates plasma concentrations of the administered xanthophylls and the optical density after 4 weeks of intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients with non exudative age-related maculopathy

Exclusion Criteria:

• intake of dietary supplements containing lutein and zeaxanthin

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

Dietary Supplement:
• Verum
10 subjects consume for 4 weeks a beverage containing 10 mg lutein and 3 mg zeaxanthin per day
• Placebo
10 subjects consume for 4 weeks a placebo beverage without any lutein and zeaxanthin

Locations

Country	Name	City	State
Germany	Friedrich Schiller University	Jena	Thuringia

Sponsors (1)

Lead Sponsor	Collaborator
University of Jena

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optical density of macular pigment in AMD patients		10 weeks	No
Secondary	Concentration of xanthophylls in plasma of AMD patients		10 weeks	No
Secondary	blood lipids		10 weeks	No