Condition category
Eye Diseases
Date applied
25/06/2018
Date assigned
28/06/2018
Last edited
27/06/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://umanitoba.ca/

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

Publication citations

Additional files

Editorial Notes