NCT01316198

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 16, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

July 27, 2012

Status Verified

July 1, 2012

Enrollment Period

1 year

First QC Date

March 15, 2011

Last Update Submit

July 26, 2012

Conditions

Age-Related Macular Degeneration

Keywords

human studyAMDluteinzeaxanthinoptical density

Outcome Measures

Primary Outcomes (1)

  • Optical density of macular pigment in AMD patients

    10 weeks

Secondary Outcomes (2)

  • Concentration of xanthophylls in plasma of AMD patients

    10 weeks

  • blood lipids

    10 weeks

Study Arms (2)

Lutein and zeaxanthin

EXPERIMENTAL
Dietary Supplement: Verum

Placebo

EXPERIMENTAL
Dietary Supplement: Placebo

Interventions

VerumDIETARY_SUPPLEMENT

10 subjects consume for 4 weeks a beverage containing 10 mg lutein and 3 mg zeaxanthin per day

Lutein and zeaxanthin
PlaceboDIETARY_SUPPLEMENT

10 subjects consume for 4 weeks a placebo beverage without any lutein and zeaxanthin

Placebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with non exudative age-related maculopathy

You may not qualify if:

  • intake of dietary supplements containing lutein and zeaxanthin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Friedrich Schiller University

Jena, Thuringia, 07743, Germany

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

calcium D-pantothenate, L-cysteine drug combination

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Volker Boehm, Dr.

    Friedrich Schiller University Jena, Institute of Nutrition, RG Bioactice Plant Products

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Volker Böhm

Study Record Dates

First Submitted

March 15, 2011

First Posted

March 16, 2011

Study Start

June 1, 2010

Primary Completion

June 1, 2011

Study Completion

July 1, 2011

Last Updated

July 27, 2012

Record last verified: 2012-07

Locations

DE(1)