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
67 East Park Place
Suite 500
Morristown
07960
United States of America
+1 (0)908 477 6953
v.juturu@omniactives.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
OmniActive Health Technologies
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United States of America
Results and Publications
Publication and dissemination plan
Intention to publish date
30/12/2015
Participant level data
Available on request
Basic results (scientific)
Publication list
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