The Effects of a Carotenoid Intervention on Cognitive Function

Mild Cognitive Impairment Clinical Trial

Official title:

The Effects of a Lutein + Zeaxanthin Intervention on Cognitive Function and Neural Efficiency

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02023645
• Other study ID #: 2012-10516
• Status: Active, not recruiting
• Phase: N/A
• First received: December 16, 2013
• Last updated: May 26, 2015
• Start date: January 2012
• Est. completion date: December 2015

Study information

• Verified date: May 2015
• Source: University of Georgia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Past research suggests that retinal lutein levels are related to cognitive function as measured via behavioral tests. The goal of the present study is to investigate the relationship between lutein and cognitive function in a wider variety of the population (young, healthy adults and older adults), using a wider variety of methods (behavioral testing and neuroimaging).

Description:

Past research suggests that retinal lutein levels are related to cognitive function as measured via behavioral tests. The goal of the present study is to investigate the relationship between lutein and cognitive function in a wider variety of the population (young, healthy adults and older adults), using a wider variety of methods (behavioral testing and neuroimaging).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• visual acuity correctable to 20:40 or better, Snellen notation

• able to swallow a dietary supplement

• free of dementia, characterized by a score of less than 1.5 on the Clinical Dementia Rating Scale

Exclusion Criteria:

• GI conditions that interfere with lipid absorption

• presence of or past diagnosis of age-related macular degeneration

• visual acuity poorer than 20:40, Snellen notation

• has taken lutein, omega-3 fatty acid or fish oil supplements within the last 6 months

• presence of dementia, characterized by a score of 1.5 or greater on the Clinical Dementia Rating Scale

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment

Intervention

Dietary Supplement:
• active supplement
tablet

Other:
• placebo
tablet

Locations

Country	Name	City	State
United States	The University of Georgia	Athens	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
University of Georgia	Abbott Nutrition, DSM Nutritional Products, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	macular pigment optical density	optical density of macular pigment layer in central retina, defined in log units of optical density	12 months	No
Secondary	serum carotenoid levels	serum carotenoids will be measured via high performance liquid chromatography	12 months	No
Secondary	reaction time	reaction (msec) to a light stimulus	12-months	No
Secondary	executive function	computerized composite score from computerized battery	12-months	No
Secondary	short-term memory	composite score from a computerized battery	12-months	No
Secondary	visual attention	composite score from computerized battery	12-months	No