Effects of Xanthophylls on Optical Density

Sponsor

University of Jena (Other)

Overall Status

Completed

CT.gov ID

NCT01316198

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Age-Related Macular Degeneration	Dietary Supplement: Verum Dietary Supplement: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lutein and zeaxanthin	Dietary Supplement: Verum 10 subjects consume for 4 weeks a beverage containing 10 mg lutein and 3 mg zeaxanthin per day
Experimental: Placebo	Dietary Supplement: Placebo 10 subjects consume for 4 weeks a placebo beverage without any lutein and zeaxanthin

Arm

Intervention/Treatment

Experimental: Lutein and zeaxanthin

Dietary Supplement: Verum

10 subjects consume for 4 weeks a beverage containing 10 mg lutein and 3 mg zeaxanthin per day

Experimental: Placebo

Dietary Supplement: Placebo

10 subjects consume for 4 weeks a placebo beverage without any lutein and zeaxanthin

Outcome Measures

Primary Outcome Measures

Optical density of macular pigment in AMD patients [10 weeks]

Secondary Outcome Measures

Concentration of xanthophylls in plasma of AMD patients [10 weeks]
blood lipids [10 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients with non exudative age-related maculopathy

Exclusion Criteria:

intake of dietary supplements containing lutein and zeaxanthin

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Friedrich Schiller University	Jena	Thuringia	Germany	07743

Sponsors and Collaborators

University of Jena

Investigators

Principal Investigator: Volker Boehm, Dr., Friedrich Schiller University Jena, Institute of Nutrition, RG Bioactice Plant Products

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Volker Boehm, Dr. Volker Böhm, University of Jena

ClinicalTrials.gov Identifier:

NCT01316198

Other Study ID Numbers:

BioPlant-LZ-AMD2011

First Posted:

Mar 16, 2011

Last Update Posted:

Jul 27, 2012

Last Verified:

Jul 1, 2012

Keywords provided by Volker Boehm, Dr. Volker Böhm, University of Jena

Additional relevant MeSH terms:

Macular Degeneration

Study Results

No Results Posted as of Jul 27, 2012