ISRCTN - ISRCTN54990825: Effects of three levels of macular carotenoid supplementation on macular pigment optical density, psychological stress levels, and overall health

Plain English Summary

Background and study aims
Given the many benefits of a diet rich in lutein, and relatively high amount of lutein in the body tissues, a pressing question going forward involves the response kinetics of people to different levels of lutein in their diet; in other words, the development of reliable dose for lutein would enable us to better understand dietary need and its relationship to health and performance benefits. Moreover, given that lutein crosses the blood-brain barrier (where it appears to benefit brain function), and interacts with the immune system (as an anti-inflammatory agent), then an increased amount of lutein and zeaxanthin isomers could plausibly impact overall health, and perhaps have psychological benefits. This study seeks to address these questions.

Who can participate?
Healthy adults aged 18-25, who are non-smokers and at a healthy weight.

What does the study involve?
Participants are randomly allocated into one of four groups. Those in group 1 are given a placebo. Those in group 2 are given 6mg of lutein and 1.2mg zeaxanthin isomers (Zi). Those in group 3 are given 10mg of lutein and 2mg Zi. Those in group 4 are given 20mg of lutein and 4mg Zi. Each participant is asked to give a sample of blood (after fasting) and undergo a macular pigment optical density assessment at the start of the study and then every 2 weeks for the duration of the study (12 weeks).

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
The University of Georgia, Athens (USA)

When is the study starting and how long is it expected to run for?
March 2014 to February 2015

Who is funding the study?
OmniActive Health Technologies Inc (USA)

Who is the main contact?
Dr Vijaya Juturu
v.juturu@omniactives.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Vijaya Juturu

ORCID ID

http://orcid.org/0000-0002-7397-715X

Contact details

67 East Park Place
Suite 500
Morristown
07960
United States of America
+1 (0)908 477 6953
v.juturu@omniactives.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

LAMA STUDY I

Study information

Scientific title

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

Acronym

Study hypothesis

Given the many benefits of a diet rich in lutein, and relatively high tissue densities of lutein, a pressing question going forward involves the response kinetics of people to different levels of lutein ingestion; in other words, the development of reliable dose / response curves for lutein would enable us to better understand dietary need and its relationship to health and performance benefits. Moreover, given that lutein crosses the blood-brain barrier (where it appears to confer cognitive benefit), and interacts with the immune system (as an anti-inflammatory agent), then increased systemic lutein and zeaxanthin isomers could plausibly impact overall health, and perhaps psychological variables such as stress. Our study seeks to address these questions.

Ethics approval

The University of Georgia Office of the Vice President for Research Institutional Review Board, 19/03/2014, ref: STUDY00000711

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Effect of lutein supplementation

Intervention

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

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

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 outcome measures

1. Oxidative stress
2. Inflammation
3. Macular carotenoids
4. Brain health markers

Measured at baseline and every two weeks over a 12-week period

Overall trial start date

19/03/2014

Overall trial end date

20/02/2015

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

N=32

Participant 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

Recruitment start date

19/03/2014

Recruitment end date

19/04/2014

Locations

Countries of recruitment

United States of America

Trial participating centre

The University of Georgia
UGA Psychology Department 125 Baldwin Street
Athens
30602
United States of America

Sponsor information

Organisation

OmniActive Health Technologies Inc.

Sponsor details