Back to resultsEffects of Xanthophylls on Optical Density
Primary Purpose
Age-Related Macular Degeneration
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Verum
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Age-Related Macular Degeneration focused on measuring human study, AMD, lutein, zeaxanthin, optical density
Eligibility Criteria
Inclusion Criteria:
- patients with non exudative age-related maculopathy
Exclusion Criteria:
- intake of dietary supplements containing lutein and zeaxanthin
Sites / Locations
- Friedrich Schiller University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Lutein and zeaxanthin
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Optical density of macular pigment in AMD patients
Secondary Outcome Measures
Concentration of xanthophylls in plasma of AMD patients
blood lipids
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01316198
Brief Title
Effects of Xanthophylls on Optical Density
Official Title
Alteration of Optical Density and Plasma Xanthophylls After Short Term Supplementation With Macular Carotenoids in Patients With AMD
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jena
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
Keywords
human study, AMD, lutein, zeaxanthin, optical density
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lutein and zeaxanthin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Verum
Intervention Description
10 subjects consume for 4 weeks a beverage containing 10 mg lutein and 3 mg zeaxanthin per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
10 subjects consume for 4 weeks a placebo beverage without any lutein and zeaxanthin
Primary Outcome Measure Information:
Title
Optical density of macular pigment in AMD patients
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Concentration of xanthophylls in plasma of AMD patients
Time Frame
10 weeks
Title
blood lipids
Time Frame
10 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with non exudative age-related maculopathy
Exclusion Criteria:
intake of dietary supplements containing lutein and zeaxanthin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Volker Boehm, Dr.
Organizational Affiliation
Friedrich Schiller University Jena, Institute of Nutrition, RG Bioactice Plant Products
Official's Role
Principal Investigator
Facility Information:
Facility Name
Friedrich Schiller University
City
Jena
State/Province
Thuringia
ZIP/Postal Code
07743
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Effects of Xanthophylls on Optical Density
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