Condition category
Eye Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

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

Trial website

Contact information



Primary contact

Dr Frank Eperjesi


Contact details

Aston University
Aston Triangle
B4 7ET
United Kingdom
‎+44 121 204 4242

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Assessing the effects of supplementation with Nutrof® Total on macular pigment optical density


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


Secondary study design

Non randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Macular pigment, eye health, age related macular degeneration.


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



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


Overall trial end date


Reason abandoned (if study stopped)


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




Target number of participants


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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Aston University
B4 7ET
United Kingdom

Sponsor information


Spectrum Thea Pharmaceuticals (UK)

Sponsor details

Fernbank House
Springwood Way
SK10 2XA
United Kingdom
+44 (0)845 521 1290

Sponsor type




Funder type

Research organisation

Funder name

Technology Strategy Board (UK)

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

For-profit companies (industry)


United Kingdom

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Publication citations

Additional files

Editorial Notes

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