Effects of Xanthophylls on Optical Density

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Volker Boehm, University of Jena
ClinicalTrials.gov Identifier:
NCT01316198
First received: March 15, 2011
Last updated: July 26, 2012
Last verified: July 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Jena:

Primary Outcome Measures:
  • Optical density of macular pigment in AMD patients [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Concentration of xanthophylls in plasma of AMD patients [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • blood lipids [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: June 2010
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with non exudative age-related maculopathy

Exclusion Criteria:

  • intake of dietary supplements containing lutein and zeaxanthin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01316198

Locations
Germany
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
  More Information

No publications provided

Responsible Party: Volker Boehm, Dr. Volker Böhm, University of Jena
ClinicalTrials.gov Identifier: NCT01316198     History of Changes
Other Study ID Numbers: BioPlant-LZ-AMD2011
Study First Received: March 15, 2011
Last Updated: July 26, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University of Jena:
human study
AMD
lutein
zeaxanthin
optical density

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

ClinicalTrials.gov processed this record on April 15, 2014