Effects of three levels of macular carotenoid supplementation on macular pigment optical density, psychological stress levels, and overall health

Completed

• Conditions: Effect of lutein supplementation; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN54990825
• Lead Sponsor: OmniActive Health Technologies Inc.

Brief Summary

2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27857944 2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27426932 2016 results in: http://www.oatext.com/Bioavailability-of-lutein-zeaxanthin-isomers-and-macular-pigment-optical-density-response-to-macular-carotenoid-supplementation-A-randomized-double-blind-placebo-controlled-study.php

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2015-02-20
• Study Start: 2015-08-24
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Healthy volunteers
2. Aged 18-25 years
3. Subjects willing to sign consent form
4. Subjects willing to participate for 3 month study
5. Non smoker
6. Normal BMI

Exclusion Criteria

1. Body Mass Index of 27 or greater
2. Macular pigment optical density (MPOD) of 0.70 or higher
3. Ocular disease or insufficient visual acuity
4. Subjects who have chronic or systemic disease
5. Current smokers
6. Subjects who are on psychiatric medication

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. MPOD, assessed with a non-invasive, perceptual task called customized heterochromatic flicker photometry (cHFP; Stringham et al. 2008). A densitometer (Macular Metrics Corp., Rehoboth, MA) described by Wooten et al. (1999) was used for this purpose. Measurements were taken at baseline and every 2 weeks over the 12-week study period. We obtained spatial profiles of MPOD at each visit, with measures at 10 degrees, 20 degrees, 30 degrees, 1.75 degrees, and 2.75 degrees of retinal eccentricity. <br>2. Psychological stress and overall health status <br>2. Cortisol<br><br>Measured at baseline and every two weeks over a 12-week period

Secondary Outcome Measures

Name	Time	Method
1. Oxidative stress<br>2. Inflammation<br>3. Macular carotenoids<br>4. Brain health markers<br><br>Measured at baseline and every two weeks over a 12-week period