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

Effect of macular carotenoid supplementation on macular pigment optical density, psychological stress levels and overall health status

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN54990825

Enrollment

Registered

2015-08-24

Start date

2014-03-19

Completion date

Unknown

Last updated

2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effect of lutein supplementation Nutritional, Metabolic, Endocrine

Interventions

1. Placebo 2. Lutein 6 mg, zeaxanthin isomers (Zi) 1.2 mg 3. Lutein 10 mg, Zi 2 mg 4. Lutein 20 mg, Zi 4 mg

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. 2. Psychological stress and overall health status 2. Cortisol Measured at baseline and every two weeks over a 12-week period	—

Measure

Time frame

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. 2. Psychological stress and overall health status 2. Cortisol Measured at baseline and every two weeks over a 12-week period

—

Secondary

Measure	Time frame
1. Oxidative stress 2. Inflammation 3. Macular carotenoids 4. Brain health markers Measured at baseline and every two weeks over a 12-week period	—

Countries

United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 12, 2026