Condition category
Nutritional, Metabolic, Endocrine
Date applied
14/07/2020
Date assigned
30/07/2020
Last edited
25/08/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

Plain English Summary

Background and study aims
Macular carotenoids are important nutrients that accumulate inside the eye, in the centre of the retina (macula). They have an important role in preserving vision since they protect against light-induced oxidative damage and can improve visual performance. Macular carotenoids have also been found in other areas of the body, like the brain. Studies have also shown they can improve certain cognitive domains such as memory, and they have been used as antioxidants in cardiometabolic diseases (i.e. heart attack, atherosclerosis, etc). Macular carotenoids are dietary of origin, which means that the human body cannot make them and their only source is from certain fruits and vegetables. The supplements used in this study are considered a major source of them, since they contain natural extracts of macular carotenoids obtained from marigolds. The aim of this study is to investigate the impact on the human body of different carotenoid formulations in nutritional supplements by measuring response in serum (blood) concentrations, as well as change in macular pigment, visual function, cognitive function, and metabolism.

Who can participate?
Healthy volunteers, between 18 and 60 years old

What does the study involve?
Participants are asked to take either a supplement containing the macular carotenoids with or without fish oil, or a placebo (dummy tablet) on a daily basis for 6 months; participants are assigned to one of six different groups and neither the participants nor the investigators will know if they are consuming the supplement or the placebo until the end of the study. Each participant will attend the Nutrition Research Centre Ireland, Waterford Institute of Technology, West Campus, Carriganore, Waterford, for three study visits over a 6-month period. There are two main visits, at the start (first visit) and at the end (last visit) of the trial, and a short visit at month 3 only for a fasting blood sample. The main visits last about 2 hours 30 minutes, whereas the study visit for blood samples lasts no more than 10 minutes.

What are the possible benefits and risks of participating?
The researchers draw a fasting blood sample and perform ocular dilation in one eye; however, no risks to participants are foreseen. Participation in this study is not a substitute for standard medical care or eye care. It is anticipated that society will benefit from this study. At the end of the study, the researchers will provide a full report on the evaluations performed to you. The participant will be given feedback and gain knowledge on their vision status, cognitive evaluation and macular pigment levels as well as nutritional information and general health recommendations. They will be informed on their macular pigment, which is of note as research has suggested that a person’s macular pigment level is a good indicator of overall eye health and brain function.

Where is the study run from?
Waterford Institute of Technology (Ireland)

When is the study starting and how long is it expected to run for?
April 2017 to December 2018

Who is funding the study?
Waterford Institute of Technology Co-Fund Scholarship: Nutrition Research Centre Ireland, Waterford Institute of Technology and Enterprise Partner: Industrial Organica (Mexico)

Who is the main contact?
1. Dr Marina Green
+353 (0) 51306261
2. Prof. John Nolan
jmnolan@wit.ie

Trial website

Contact information

Type

Scientific

Primary contact

Prof John Nolan

ORCID ID

http://orcid.org/0000-0002-5503-7084

Contact details

Waterford Institute of Technology
Carriganore House
WIT West Campus
Carriganore
Waterford
X91 K236
Ireland
+353 (0)51 834074
jmnolan@wit.ie

Type

Public

Additional contact

Dr Marina Green

ORCID ID

http://orcid.org/0000-0002-3324-244X

Contact details

Waterford Institute of Technology
Carriganore House
WIT West Campus
Carriganore
Waterford
X91K236
Ireland
+353 (0)51 306261
mgreen@wit.ie

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

The impact of formulation on lutein, zeaxanthin, and meso-zeaxanthin bioavailability: a randomized double-blind placebo-controlled study

Acronym

COAST (the Carotenoid-Omega bio-Availability STudy)

Study hypothesis

The hypotheses were (a) that the active intervention groups (unrelated treatments) would all have a higher average response, after 6 months, in serum and in tissue concentrations compared with the placebo group, and (b) that the diacetate intervention would have a higher average response as compared with the other three active intervention groups.

Ethics approval

1. Approved 26/05/2017, Research Ethics Committee of Waterford Institute of Technology (Waterford, Ireland; +353 (0)51 302000; ethics@wit.ie), ref: 17/HS-MPRG/01
2. Approved 24/05/2017, Research Ethics Committee of the HSE, South Eastern Area (Waterford Regional Hospital, Waterford, Ireland; +353 (0)51 842026; caroline.lamb2@hse.ie), ref: not provided

Study design

Six-arm intervention study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

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

Condition

The impact of formulation on lutein, zeaxanthin, and meso-zeaxanthin bioavailability in a healthy Irish adult sample

Intervention

Participants were blocked randomized, with equal probability and separately for men and women, to one of five active intervention groups, or to a placebo group. Block randomization was performed using a trial management system, “Trial Controller”, designed by the research group. Participants take on a daily basis for 6 months:

Group 1: lutein (L) (10 mg) + meso-zeaxanthin (MZ) (10 mg) + zeaxanthin (Z) (2 mg) provided in one capsule
Group 2: L (10 mg) + MZ (10 mg) + Z (2 mg) provided in two capsules
Group 3: L (10 mg) + MZ (10 mg) + Z (2 mg) provided in DHA/EPA (430 mg/ 90 mg) in two capsules
Group 4: L (10 mg) + MZ (10 mg) + Z (2 mg) diacetates provided in micromicellar formulation in one capsule
Group 5: L (5 mg lutein) = MZ (15 mg) + Z (1 mg) provided in 1 g of fish oil in two capsules
Group 6: placebo (sunflower oil)

Neither the participants nor the investigators will know if they are consuming the supplement or the placebo until the end of the study.

Each volunteer will attend the Nutrition Research Centre Ireland, Waterford Institute of Technology, West Campus, Carriganore, Waterford, for three study visits over a 6-month period. There are two main visits, at the start (first visit) and at the end (last visit) of the trial, and a short visit at month 3 only for a fasting blood sample. The main visits last approximately 2 h 30 min, whereas the study visit for blood samples lasts no more than 10 minutes.

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

Lutein, zeaxanthin, and meso-zeaxanthin bioavailability measured in serum, macular pigment, and skin using high-performance liquid chromatography (HPLC), the Spectralis investigational macular pigment optical density (MPOD) module, and the Nu Skin Pharmanex S3 scanner, respectively, at baseline and 6 months

Secondary outcome measures

1. Serum lipid concentrations measured from a blood sample using mass spectrometry at baseline and 6 months
2. DHA and EPA measured from a blood sample using gas chromatography at baseline and 6 months
3. Visual function measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) logarithm of the minimum angle of resolution (LogMAR) chart (Test Chart 2000 PROTM) for Best-corrected visual acuity (BCVA); the LogMAR EDTRS (Test Chart 2000 PROTM) for Letter Contrast Sensitivity (CS); the “Advanced Vision and Optometric Tests” (AVOT) for visual acuity, contrast sensitivity, cone and rod vision; at baseline and 6 months
4. Cognitive function measured using tests of attention, memory, executive function and decision making from the Cambridge Neuropsychological Test Automated Battery (CANTAB, Cambridge Cognition, UK) at baseline and 6 months
5. Medical information obtained through a questionnaire and physical examination at baseline and 6 months

Overall trial start date

01/04/2017

Overall trial end date

19/12/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Healthy adults
2. Age group between 18 and 65 years

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

96

Total final enrolment

97

Participant exclusion criteria

1. A medical diagnosis of a critical or acute medical condition
2. Intake of nutritional supplements containing lutein, zeaxanthin, meso-zeaxanthin or omega-3 fatty acids

Recruitment start date

01/09/2017

Recruitment end date

03/07/2018

Locations

Countries of recruitment

Ireland

Trial participating centre

Nutrition Research Centre Ireland
Waterford Institute of Technology, West Campus
Waterford
X91K236
Ireland

Sponsor information

Organisation

Waterford Institute of Technology

Sponsor details

Nutrition Research Centre Ireland
Carriganore House
West Campus
Waterford
X91K236
Ireland
+353 (0)51 845505
info@mprg.ie

Sponsor type

University/education

Website

http://www.wit.ie

Funders

Funder type

Industry

Funder name

Industrial Organica

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Waterford Institute of Technology

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Primary outcomes will be published in an initial publication in a high-impact peer-reviewed journal, followed by subsequent publications focused on secondary outcomes.

IPD sharing statement
The data-sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/08/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

2020 results in https://pubmed.ncbi.nlm.nih.gov/32824736/ (added 25/08/2020)

Publication citations

Additional files

Editorial Notes

25/08/2020: Publication reference added. 17/07/2020: Trial's existence confirmed by Research Ethics Committees of the Waterford Institute of Technology.