LAD: Lutein and Alzheimer's Disease Study

Sponsor

Oregon Health and Science University (Other)

Overall Status

Terminated

CT.gov ID

NCT00596024

Collaborator

Oregon Partnership for Alzheimer's Research (Other)

Enrollment

Location

Arms

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease	Dietary Supplement: lutein/zeaxanthin Dietary Supplement: placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Lutein and Oxidative Stress in Alzheimer's Disease - A Pilot Study

Study Start Date :

Dec 1, 2007

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Daily Lutein/zeaxanthin supplementation with a meal	Dietary Supplement: lutein/zeaxanthin daily supplementation of lutein and zeaxanthin at dose of 12 mg/day
Placebo Comparator: 2	Dietary Supplement: placebo placebo capsules with the same size and coating as those of lutein/zeaxanthin supplements without active ingredients

Arm

Intervention/Treatment

Experimental: 1

Daily Lutein/zeaxanthin supplementation with a meal

Dietary Supplement: lutein/zeaxanthin

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

Placebo Comparator: 2

Dietary Supplement: placebo

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

Outcome Measures

Primary Outcome Measures

oxidative damage markers [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosed with moderately severe Alzheimer's disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oregon Health and Science University	Portland	Oregon	United States	97239

Sponsors and Collaborators

Oregon Health and Science University
Oregon Partnership for Alzheimer's Research

Investigators

Principal Investigator: Wei Wang, PhD, Oregon Health and Science University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Oregon Health and Science University

ClinicalTrials.gov Identifier:

NCT00596024

Other Study ID Numbers:

LAD
Alzheimer research fund

First Posted:

Jan 16, 2008

Last Update Posted:

Aug 12, 2019

Last Verified:

Aug 1, 2019

Additional relevant MeSH terms:

Alzheimer Disease

Study Results

No Results Posted as of Aug 12, 2019