Effects of Xanthophylls on Optical Density

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01316198
Recruitment Status : Completed
First Posted : March 16, 2011
Last Update Posted : July 27, 2012
Information provided by (Responsible Party):
Volker Boehm, University of Jena

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
Age-Related Macular Degeneration Dietary Supplement: Verum Dietary Supplement: Placebo

Study Type : Interventional  (Clinical Trial)
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 : June 2010
Primary Completion Date : June 2011
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Lutein
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Optical density of macular pigment in AMD patients [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. Concentration of xanthophylls in plasma of AMD patients [ Time Frame: 10 weeks ]
  2. blood lipids [ Time Frame: 10 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients with non exudative age-related maculopathy

Exclusion Criteria:

  • intake of dietary supplements containing lutein and zeaxanthin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01316198

Friedrich Schiller University
Jena, Thuringia, Germany, 07743
Sponsors and Collaborators
University of Jena
Principal Investigator: Volker Boehm, Dr. Friedrich Schiller University Jena, Institute of Nutrition, RG Bioactice Plant Products

Responsible Party: Volker Boehm, Dr. Volker Böhm, University of Jena Identifier: NCT01316198     History of Changes
Other Study ID Numbers: BioPlant-LZ-AMD2011
First Posted: March 16, 2011    Key Record Dates
Last Update Posted: July 27, 2012
Last Verified: July 2012

Keywords provided by Volker Boehm, University of Jena:
human study
optical density

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases