Assessing the effects of supplementation with Nutrof® Total on the ability of the eye to filter blue light

ISRCTN	ISRCTN79841039
DOI	https://doi.org/10.1186/ISRCTN79841039
Secondary identifying numbers	N/A

Submission date: 11/11/2013
Registration date: 21/11/2013
Last edited: 23/01/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Frank Eperjesi
Scientific

Aston University
Aston Triangle
Birmingham
B4 7ET
United Kingdom

Phone	‎+44 121 204 4242
Email	f.eperjesi@aston.ac.uk

Study information

Study design	Open label multi-centre intervention study
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Assessing the effects of supplementation with Nutrof® Total on macular pigment optical density
Study objectives	Supplementation over 6 months with Nutrof® Total should increase macular pigment levels, when measured with Tinsley MPOD®.
Ethics approval(s)	Aston University Ethics Committee, 02/09/2013, REC Reference: Ethics Application 531
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	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 study start date	02/09/2013
Completion date	01/08/2014

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Both
Target number of participants	32
Key inclusion criteria	1. Healthy volunteers recruited from local optometrists 2. Male or female 3. Aged 50 or older
Key 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
Date of first enrolment	02/09/2013
Date of final enrolment	01/08/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Aston University

Birmingham
B4 7ET
United Kingdom

Sponsor information

Spectrum Thea Pharmaceuticals (UK)
Industry

Fernbank House
Springwood Way
Macclesfield
SK10 2XA
United Kingdom

Phone	+44 (0)845 521 1290
Email	enquiries@spectrum-thea.co.uk
"ROR"	https://ror.org/04edz9p52

Funders

Funder type

Research organisation

Technology Strategy Board (UK)
Private sector organisation / For-profit companies (industry)

Alternative name(s): TSB
Location: United Kingdom

Aston University (UK) - Spectrum Thea Pharmaceuticals (UK) - Knowledge Transfer Partnership (KTP)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

23/01/2017: No publications found in PubMed, verifying study status with principal investigator.