Condition category
Eye Diseases
Date applied
23/03/2016
Date assigned
22/04/2016
Last edited
22/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In the retina (the layer at the back of the eye which is sensitive to light), there is a yellow pigment called macular pigment. This pigment is made up of three carotenoids (lutein, zeaxanthin and meso-zeaxanthin). These carotenoids are obtained from the diet and are thought to be important for preserving and improving vision. This study is going to look at the relationship between macular carotinoids and visual function in order to find out if taking a supplement called Lutemax 2020 (which contains lutein and zeaxanthin) can help to improve contrast sensitivity, visual processing and glare sensitivity.

Who can participate?
Adults aged between 18 and 25 who are exposed daily to high energy sources such as UV, blue light and electronic devices such as TV, computer , IPAD and cell phones for at least more than four hours per day.

What does the study involve?
Participants are randomly allocated to one of two groups. Participants in the first group take a capsule of Lutemax 2020, which contains 20 mg Lutein and 4 mg Zeaxanthin, once a day for six months. Participants in the second group take a capsule containing safflower oil, which acts as a placebo (dummy), once a day for six months. Participants in both groups undergo a number of visual tests as well as providing a blood sample so that lutein levels can be measured. In addition, participants also complete a number of questionnaires in order to measure their general health cognitive function (thinking, processing and memory).

What are the possible benefits and risks of participating?
Participants may benefit from learning more about their own visual function and the role that macular carotinoids play. There are no significant risks involved but some participants may experience pain, bleeding or bruising following blood sample collection.

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

When is the study starting and how long is it expected to run for?
May 2015 to February 2016

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Ms Nafisah B Atako
mrcctu.stophcv1@ucl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Vijaya Juturu

ORCID ID

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

Contact details

OmniActive Health Technologies Inc.
67 East Park Place
Suite 500
Morristown
07960
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BL Study I and II/

Study information

Scientific title

Macular carotenoids and blue light: Relationships with visual performance, sleep, health, and quality of life

Acronym

Study hypothesis

The aim of this study is to evaluate the effects of macular carotenoids on visual function tests and sleep improvement over placebo.

Ethics approval

The University of Georgia Office of the Vice President for Research Institutional Review Board, 19/06/2015, ref: 00001914

Study design

Double-blind randomized placebo 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 the contact details below to request a patient information sheet.

Condition

Eye damage

Intervention

Participants are randomly allocated to one of two study groups.

Intervention group: Participants take a capsule of Lutemax 2020, which contains 20 mg Lutein and 4 mg Zeaxanthin isomers, once a day for six months.
Control group: Participants take a capsule containing a placebo (safflower oil) once a day for six months.

Participants attend study visits at baseline, 3 and 6 months.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

1. Contrast sensitivity is determined using a computer-based, 2-alternative, forced-choice procedure at baseline, 3 and 6 months
2. Glare sensitivity is measured using the disability glare performance task and the photostress recovery performance task at baseline, 3 and 6 months
3. Macular pigment optical density is assessed via heterochromatic flicker photometry at baseline, 3 and 6 months

Secondary outcome measures

1. Psychological stress is measured using the Psychological Stress Measure (PSM-9) and the Brief Symptom Inventory (BSI) at baseline, 3 and 6 months
2. Lutein concentration is measured by High-Performance Liquid Chromatography (HPLC) and Enzyme-linked Immune Sorbent Assay (ELISA) using blood samples at baseline, 3 and 6 months
3. General health status is measured at baseline, 3 and 6 months using the following:
25-item Suboptimal Health Status Questionnaire (SHSQ-25).
3.1. SCL 90-r overall affect assessment
3.2. Beck Depression Inventory
3.3. Beck Anxiety Inventory
3.4. Dietary Questionnaire
3.5. A standard cognitive battery (RBANS-update)
3.6. The Pittsburgh Sleep Quality Index (PSQI)
3.7. A questionnaire on different attributes including frequencies such as head ache, eye strain and eye fatigues will be questioned before and after supplementation

Overall trial start date

02/05/2015

Overall trial end date

03/02/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Two-three hours of outside activity per day will be recruited with preference, due to blue light exposure
2. MPOD of subjects ≤0.69
3. One or more of the following symptoms:
3.1. Accommodative issues (difficulty seeing in the distance after prolonged nearwork)
3.2. Digital eyestrain
3.3. Blurry vision
3.4. Difficulty focusing
3.5. Dry and irritated eyes
3.6. Headaches
3.7. Neck and/or back pain
4. Aged 18 to 25 years

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

N=45

Participant exclusion criteria

1. Body Mass Index of 30 or greater
2. Macular pigment optical density (MPOD) of 0.70 or higher
3. Ocular disease or insufficient visual acuity (cut off 20/30 visual acuity)
4. Systemic disease or any chronic disease condition
5. Smokers
6. Current use of psychiatric medication

Recruitment start date

16/05/2015

Recruitment end date

18/06/2015

Locations

Countries of recruitment

United States of America

Trial participating centre

University of Georgia
UGA Psychology Department 125 Baldwin Street Athens
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

Sponsor type

Industry

Website

http://www.omniactives.com

Funders

Funder type

Industry

Funder name

OmniActive Health Technologies Inc.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

Intention to publish date

12/12/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes