MedDataX Logo

Effects of Xanthophylls on Optical Density

NCT ID: NCT01316198

Last Updated: 2012-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Age-Related Macular Degeneration

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

human study AMD lutein zeaxanthin optical density

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lutein and zeaxanthin

Group Type EXPERIMENTAL

Verum

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Verum

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients with non exudative age-related maculopathy

Exclusion Criteria

* intake of dietary supplements containing lutein and zeaxanthin
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Jena

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Volker Boehm

Dr. Volker Böhm

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Volker Boehm, Dr.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Friedrich Schiller University

Jena, Thuringia, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BioPlant-LZ-AMD2011

Identifier Type: -

Identifier Source: org_study_id