Effects of lutein and omega-3 fat enriched egg consumption on visual function in older adults: Implications for age-related macular degeneration

ISRCTN	ISRCTN45308629
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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Mrs Chelsey Walchuk
Scientific

409 Tache Ave, Lab R4052
Winnipeg
R2H 2A6
Canada

Phone	+1 (0)204 997 5286
Email	umwalchu@myumanitoba.ca

Study information

Study design	Single-centre 6-week intervention trial with a repeated measure design
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
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

Richardson Centre for Functional Foods and Neutraceuticals

196 Innovation Drive
University of Manitoba, SmartPark
Winnipeg
R3T 6C5
Canada

Sponsor information

University of Manitoba
University/education

66 Chancellors Circle
Winnipeg
R3T 2N2
Canada

Website	http://umanitoba.ca/
"ROR"	https://ror.org/02gfys938

Funders

Funder type

Research organisation

Agri-Food Research and Development Initiative’s (ARDI) Growing Forward program

No information available

Manitoba Egg Farmers

No information available

Burnbrae Farms Inc.

No information available

Results and Publications

Intention to publish date	01/07/2018
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).