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 |
| Protocol serial number | N/A |
| Sponsor | Spectrum Thea Pharmaceuticals (UK) |
| Funders | Technology Strategy Board (UK), Aston University (UK) - Spectrum Thea Pharmaceuticals (UK) - Knowledge Transfer Partnership (KTP) |
- 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
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
Scientific
Aston University
Aston Triangle
Birmingham
B4 7ET
United Kingdom
| Phone | +44 121 204 4242 |
|---|---|
| f.eperjesi@aston.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open label multi-centre intervention study |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Nutrof® Total |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/08/2014 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
B4 7ET
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
23/01/2017: No publications found in PubMed, verifying study status with principal investigator.
