Condition category
Eye Diseases
Date applied
11/11/2013
Date assigned
21/11/2013
Last edited
21/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
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, 2nd September 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 measures

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes