Plain English Summary
Background and study aims
Nutrof® Total contains nutrients considered essential for effective protection of the eye from harmful blue light (light from electronic devices such as laptop, mobile, etc). Taking the supplement for an extended time should result in a more effective filter of this blue light i.e. the supplements should increase the macular pigment levels which will protect the retina from the harmful blue light.
Who can participate?
Healthy volunteers aged 50+, who do not have diabetes, are not pregnant or planning to become pregnant, are not taking oral contraceptives, do not have a history of estrogen sensitive cancers, are not taking warfarin, do not have neovascular age-related macular degeneration (an eye disease), and have no other ocular pathologies that may interfere.
What does the study involve?
All participants will have to take one food supplement capsule (Nutrof® Total) daily, for 6 months.
After 6 months the changes in blue light filtration will be measured. Blue light filtration is measured using a simple test where the time taken for a user to notice a flickering light is measured and will be carried out at 0 days, 21 days, 3 months and 6 months.
What are the possible benefits and risks of participating?
Nutrof® Total is a nutritional supplement that aims to ensure you have adequate levels of key nutrients essential for healthy eyes. As the ingredients can all be found to some extent in healthy diets, the only risks are from having excessive amounts of these nutrients, which may happen if the participant currently takes additional supplements. This risk will be assessed upon initial contact.
Where is the study run from?
The study is being run in the Macclesfield/Manchester area (UK) with the help of two local optometrists.
When is the study starting and how long is it expected to run for?
The study started in September 2013 and will run until August 2014.
Who is funding the study?
Technology Strategy Board (UK) and Aston University (UK).
Who is the main contact?
Adam McGuinness
mcguinna@aston.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Frank Eperjesi
ORCID ID
Contact details
Aston University
Aston Triangle
Birmingham
B4 7ET
United Kingdom
+44 121 204 4242
f.eperjesi@aston.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Assessing the effects of supplementation with Nutrof® Total on macular pigment optical density
Acronym
Study hypothesis
Supplementation over 6 months with Nutrof® Total should increase macular pigment levels, when measured with Tinsley MPOD®.
Ethics approval
Aston University Ethics Committee, 02/09/2013, REC Reference: Ethics Application 531
Study design
Open label multi-centre intervention study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Macular pigment, eye health, age related macular degeneration.
Intervention
Subjects will be required to take one food supplement capsule (Nutrof® Total) daily, for 6 months. There is no placebo. Deviation from baseline measurement will be assessed.
Intervention type
Drug
Phase
Not Applicable
Drug names
Nutrof® Total
Primary outcome measure
Macular pigment optical density (MPOD) will be measured in the patients eye using a Tinsley® MPOD. These readings will be taken at baseline, 21 days, 3 months and 6 months.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
02/09/2013
Overall trial end date
01/08/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Healthy volunteers recruited from local optometrists
2. Male or female
3. Aged 50 or older
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
32
Participant exclusion criteria
1. Type 1 and 2 diabetics
2. Pregnancy or intention to become pregnant
3. History of estrogen sensitive cancer
4. Warfarin users
5. Neovascular age-related macular degeneration (AMD) sufferers
Recruitment start date
02/09/2013
Recruitment end date
01/08/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Aston University
Birmingham
B4 7ET
United Kingdom
Sponsor information
Organisation
Spectrum Thea Pharmaceuticals (UK)
Sponsor details
Fernbank House
Springwood Way
Macclesfield
SK10 2XA
United Kingdom
+44 (0)845 521 1290
enquiries@spectrum-thea.co.uk
Sponsor type
Industry
Website
Funders
Funder type
Research organisation
Funder name
Technology Strategy Board (UK)
Alternative name(s)
TSB
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United Kingdom
Funder name
Aston University (UK) - Spectrum Thea Pharmaceuticals (UK) - Knowledge Transfer Partnership (KTP)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list