Effects of Xanthophylls on Optical Density

Overview

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.

Full Title of Study: “Alteration of Optical Density and Plasma Xanthophylls After Short Term Supplementation With Macular Carotenoids in Patients With AMD”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2011

Interventions

  • Dietary Supplement: Verum
    • 10 subjects consume for 4 weeks a beverage containing 10 mg lutein and 3 mg zeaxanthin per day
  • Dietary Supplement: Placebo
    • 10 subjects consume for 4 weeks a placebo beverage without any lutein and zeaxanthin

Arms, Groups and Cohorts

  • Experimental: Lutein and zeaxanthin
  • Experimental: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Optical density of macular pigment in AMD patients
    • Time Frame: 10 weeks

Secondary Measures

  • Concentration of xanthophylls in plasma of AMD patients
    • Time Frame: 10 weeks
  • blood lipids
    • Time Frame: 10 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • patients with non exudative age-related maculopathy

Exclusion Criteria

  • intake of dietary supplements containing lutein and zeaxanthin

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Jena
  • Provider of Information About this Clinical Study
    • Principal Investigator: Volker Boehm, Dr. Volker Böhm – University of Jena
  • Overall Official(s)
    • Volker Boehm, Dr., Principal Investigator, Friedrich Schiller University Jena, Institute of Nutrition, RG Bioactice Plant Products

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