Effects of three levels of macular carotenoid supplementation on macular pigment optical density, psychological stress levels, and overall health
| ISRCTN | ISRCTN54990825 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54990825 |
| Secondary identifying numbers | LAMA STUDY I |
- Submission date
- 31/07/2015
- Registration date
- 24/08/2015
- Last edited
- 31/07/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
67 East Park Place
Suite 500
Morristown
07960
United States of America
 ORCID ID |
0000-0002-7397-715X |
|---|---|
| Phone | +1 (0)908 477 6953 |
| v.juturu@omniactives.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Effect of macular carotenoid supplementation on macular pigment optical density, psychological stress levels and overall health status |
| Study objectives | 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(s) | The University of Georgia Office of the Vice President for Research Institutional Review Board, 19/03/2014, ref: STUDY00000711 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 19/03/2014 |
| Completion date | 20/02/2015 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 25 Years |
| Sex | Both |
| Target number of participants | N=32 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 19/03/2014 |
| Date of final enrolment | 19/04/2014 |
Locations
Countries of recruitment
- United States of America
Study participating centre
125 Baldwin Street
Athens
30602
United States of America
Sponsor information
Industry
67 East Park Place
Suite 500
Morristown
07960
United States of America
| Phone | +1 (0)908 477 6953 |
|---|---|
| v.juturu@omniactives.com | |
| Website | http://www.omniactives.com |
"ROR" |
https://ror.org/024e1pj18 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Location
- United States of America
Results and Publications
| Intention to publish date | 30/12/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 13/05/2016 | Yes | No | |
| Results article | results | 01/10/2016 | Yes | No | |
| Results article | results | 11/11/2016 | Yes | No |
Editorial Notes
31/07/2018: Publication references added.
21/11/2016: Publication reference added.
