Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Chelsey Walchuk
ORCID ID
Contact details
409 Tache Ave
Lab R4052
Winnipeg
R2H 2A6
Canada
+1 (0)204 997 5286
umwalchu@myumanitoba.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
J2013:104
Study information
Scientific title
Effects of lutein and docosahexaenoic acid enriched egg consumption in older adults: Implications for age-related macular degeneration
Acronym
Egg and Vision Study
Study hypothesis
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
University of Manitoba Joint-Faculty Research Ethics Board, 02/08/2013, Protocol #J2013:104
Study design
Single-centre 6-week intervention trial with a repeated measure design
Primary study design
Interventional
Secondary study design
Repeated measure
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
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
Phase
Drug names
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 trial start date
01/05/2013
Overall trial end date
01/09/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Individuals between 50-80 years of age
2. Caucasian ethnicity
3. Good English written and oral communication skills
Participant type
Healthy volunteer
Age group
Senior
Gender
Both
Target number of participants
30
Participant 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)
Recruitment start date
01/07/2013
Recruitment end date
01/03/2014
Locations
Countries of recruitment
Canada
Trial participating centre
Richardson Centre for Functional Foods and Neutraceuticals
196 Innovation Drive
University of Manitoba, SmartPark
Winnipeg
R3T 6C5
Canada
Sponsor information
Organisation
University of Manitoba
Sponsor details
66 Chancellors Circle
Winnipeg
R3T 2N2
Canada
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Agri-Food Research and Development Initiative’s (ARDI) Growing Forward program
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Manitoba Egg Farmers
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Burnbrae Farms Inc.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
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 statement
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).
Intention to publish date
01/07/2018
Participant level data
Available on request
Basic results (scientific)
Publication list