Lutein and Alzheimer's Disease Study

NCT ID: NCT00596024

Last Updated: 2019-08-12

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

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-07-31

Brief Summary

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Oxidative damage by free radicals may be involved in causing Alzheimer's disease (AD). Free radicals may lead to death of nerve cells and decline in brain function. Certain antioxidants may suppress this free radical damage associated with AD. Carotenoids are a family of naturally occurring antioxidants that have important functions for human health. Carotenoids are known to reduce oxidative damage, but their effects have not been studied in AD patients.

The objective of the study is to examine whether lutein supplementation helps to reduce oxidative damage from free radicals in AD patients.

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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1

Daily Lutein/zeaxanthin supplementation with a meal

Group Type EXPERIMENTAL

lutein/zeaxanthin

Intervention Type DIETARY_SUPPLEMENT

daily supplementation of lutein and zeaxanthin at dose of 12 mg/day

2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

placebo capsules with the same size and coating as those of lutein/zeaxanthin supplements without active ingredients

Interventions

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lutein/zeaxanthin

daily supplementation of lutein and zeaxanthin at dose of 12 mg/day

Intervention Type DIETARY_SUPPLEMENT

placebo

placebo capsules with the same size and coating as those of lutein/zeaxanthin supplements without active ingredients

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with moderately severe Alzheimer's disease
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oregon Partnership for Alzheimer's Research

UNKNOWN

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wei Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health and Science University

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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Alzheimer research fund

Identifier Type: -

Identifier Source: secondary_id

LAD

Identifier Type: -

Identifier Source: org_study_id

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