Effects of Xanthophylls on Optical Density
This study has been completed.
Sponsor:
University of Jena
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
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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:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
MedlinePlus related topics:
Macular Degeneration
Drug Information available for:
Lutein
U.S. FDA Resources
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 June 18, 2013