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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Eye Diseases
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on October 20, 2014