Effects of lutein and omega-3 fat enriched egg consumption on visual function in older adults: Implications for age-related macular degeneration
ISRCTN | ISRCTN45308629 |
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DOI | https://doi.org/10.1186/ISRCTN45308629 |
Secondary identifying numbers | J2013:104 |
- Submission date
- 25/06/2018
- Registration date
- 28/06/2018
- Last edited
- 27/06/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Despite ample research showing the ability of lutein, zeaxanthin and omega-3 docosahexaenoic acid (DHA) to benefit retina (eye) function, research using whole foods as a vehicle for these nutrients is lacking. As age-related macular degeneration (AMD) is common among Caucasian older adults, this study investigates whether DHA-enriched egg consumption can improve retina function in this population.
Who can participate?
Healthy Caucasian adults aged 50-80
What does the study involve?
Participants consume two lutein and DHA enriched eggs daily for six weeks, while avoiding supplements and foods high in eye-related nutrients. Rod and cone (eye) cell function is assessed by full field electroretinogram (an eye test). Blood DHA, lutein and lipid levels are measured at the start of the study and after 6 weeks.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Richardson Centre for Functional Foods and Neutraceuticals (Canada)
When is the study starting and how long is it expected to run for?
May 2013 to September 2014
Who is funding the study?
1. Agri-Food Research and Development Initiative’s (ARDI) Growing Forward program
2. Manitoba Egg Farmers
3. Burnbrae Farms Inc.
Who is the main contact?
Mrs Chelsey Walchuk
umwalchu@myumanitoba.ca
Contact information
Scientific
409 Tache Ave, Lab R4052
Winnipeg
R2H 2A6
Canada
Phone | +1 (0)204 997 5286 |
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umwalchu@myumanitoba.ca |
Study information
Study design | Single-centre 6-week intervention trial with a repeated measure design |
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Primary study design | Interventional |
Secondary study design | Repeated measure |
Study setting(s) | Other |
Study type | Prevention |
Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
Scientific title | Effects of lutein and docosahexaenoic acid enriched egg consumption in older adults: Implications for age-related macular degeneration |
Study acronym | Egg and Vision Study |
Study objectives | Lutein and DHA enriched egg consumption will improve retina function in Caucasian older adults by increasing egg-nutrient associated blood profiles while not adversely affecting plasma lipid profiles. More specifically, in Caucasian older adults, lutein and DHA enriched egg consumption will: 1. Improve self-assessed health and vision status 2. Improve electrophysiological retina function 3. Not influence TC and TAG concentrations 4. Not influence HDL-C/LDL-C particle size 5. Increase DHA in plasma and erythrocytes 6. Increase lutein in plasma |
Ethics approval(s) | University of Manitoba Joint-Faculty Research Ethics Board, 02/08/2013, Protocol #J2013:104 |
Health condition(s) or problem(s) studied | General health of the retina and prevention of age-related macular degeneration |
Intervention | Avoidance of retina/eye related food items for one month prior and throughout the duration of the trial (6 weeks) including: eggs; oysters; liver (chicken, beef, veal, etc.); sweet potato; pumpkin; carrots; kale; fish and caviar; spinach; supplements that contain zinc, choline, vitamin A, lutein, zeaxanthin and DHA. Limit retina/eye related food items for one month prior and throughout the duration of the trial (6 weeks) including: pork ham, bacon, beef, lamb, butternut squash, collard greens, turnip greens, baked beans and green peas Treatment: 2 medium (92g) lutein and docosahexaenoic acid enriched eggs (0.87 mg lutein/day, 220 mg DHA/day) daily for 6 weeks to be consumed/cooked at the discretion of the participant. Control: No control group as participants acted as their own control from PRE to DURING and POST assessment following consumption of enriched eggs. Rod and cone cell function was assessed by full field electroretinogram. Plasma and red blood cell (RBC) DHA, plasma lutein, lipid profiles, and lipoprotein subfractions were assessed at day 0 (PRE) and 6 wks (POST). |
Intervention type | Supplement |
Primary outcome measure | 1. Self-assessed health and vision status measured using a modified version of the National Eye Institute Visual Functioning Questionnaire at PRE (week 0), DURING (week 3) and POST (week 6) assessment 2. Plasma lipid profiles (Total cholesterol, HDL-cholesterol, LDL-cholesterol, Triglycerides), measured using a Cobas C 111 Analyzer at PRE (week 0), DURING (week 3) and POST (week 6) assessment 3. Plasma fatty acids, measured by gas chromatography at PRE (week 0), DURING (week 3) and POST (week 6) assessment 4. Plasma lutein, measured using high performance liquid chromatography at PRE (week 0), DURING (week 3) and POST (week 6) assessment 5. Retina function, measured using a full field electroretinogram at PRE (week 0), DURING (week 3) and POST (week 6) assessment |
Secondary outcome measures | 1. Average dietary intake, measured using a 3-day food record analyzed using The Food Processor software between DURING (week 3) and POST (week 6) assessment 2. LDL/HDL particle size, measured using polyacrylamide gel electrophoresis (Lipoprint Lipoprotein Subfractions Testing System, Quantimetrix, California, US) at PRE (week 0) and POST (week 6) assessment |
Overall study start date | 01/05/2013 |
Completion date | 01/09/2014 |
Eligibility
Participant type(s) | Healthy volunteer |
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Age group | Senior |
Sex | Both |
Target number of participants | 30 |
Key inclusion criteria | 1. Individuals between 50-80 years of age 2. Caucasian ethnicity 3. Good English written and oral communication skills |
Key exclusion criteria | 1. Individuals with an egg allergy 2. Individuals diagnosed with a chronic disease (ie. diabetes, cardiovascular disease etc) 3. Individuals diagnosed with mental cognitive disorders 4. Individuals diagnosed as hypercholesterolemic 5. Individuals taking statins and other lipid lowering medications 6. Individuals diagnosed with eye related disease (i.e. glaucoma, AMD, retinitis pigmentosa, etc) |
Date of first enrolment | 01/07/2013 |
Date of final enrolment | 01/03/2014 |
Locations
Countries of recruitment
- Canada
Study participating centre
University of Manitoba, SmartPark
Winnipeg
R3T 6C5
Canada
Sponsor information
University/education
66 Chancellors Circle
Winnipeg
R3T 2N2
Canada
Website | http://umanitoba.ca/ |
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https://ror.org/02gfys938 |
Funders
Funder type
Research organisation
No information available
No information available
No information available
Results and Publications
Intention to publish date | 01/07/2018 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Available on request |
Publication and dissemination plan | 1. The full electronic thesis for the proposed research can be obtained from http://hdl.handle.net/1993/32212 2. The trial is to be ready and submitted for publication July 2018 |
IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Miyoung Suh (miyoung.suh@umanitoba.ca) and Chelsey Walchuk (umwalchu@myumanitoba.ca). |