Enriched Eggs for Retina Health in Type 2 Diabetes
Effects of DHA and Lutein Enriched Eggs on Retina Health and Metabolic and Physical Parameters in Type 2 Diabetes: a Strategy for Diabetic Retinopathy
1 other identifier
interventional
60
1 country
1
Brief Summary
Diabetes mellitus has been declared a major public health issue. Among the complications of the disease, retinopathy can have a significant impact on mobility and quality of life for individuals living with diabetes. As the leading cause of new blindness in adults, diabetic retinopathy has been shown to affect 23% of all Type 1 and 14% of Type 2 diabetic individuals. Various studies have reported that a number of components in the egg may contribute to visual function and eye health. Specifically, i) egg yolk naturally contains, and can be further enriched with the carotenoids lutein and zeaxanthin. Lutein and zeaxanthin protect the retina against light induced retinal damage by acting as potent antioxidants that shield the retina from harmful short-wave radiation. ii) eggs can also be enriched to provide a vehicle for specific nutrients to promote eye health including omega-3 fatty acid, docosahexaenoic acid (DHA). A substantial amount of DHA is uniquely found within the retina. A DHA deficiency has shown to induce abnormal retina function indicating a constant supply of this nutrient is necessary for retina health. Currently, the American Diabetes Association declares that eggs are an excellent choice for people with diabetes, but information lacks on the status of whole egg consumption in diabetic individuals in relation to their retinal health. Therefore, the current study aims to determine if the consumption of two lutein and DHA enriched eggs per day can safely improve the retina function of individuals with type 2 diabetes. A total of 60 adult diabetic male and female participants will be recruited to take part in this double-blinded, randomized, placebo-controlled, parallel trial. Participants will be randomly assigned to include two DHA and lutein enriched eggs or regular eggs into their usual diet for 6 weeks. At the beginning and end of the trial, a variety of measures will be analyzed including blood lipid parameters, carotenoid status, anthropometrics, arterial stiffness, advanced glycated end products, macular pigment optical density and electroretinography. These measures will aid in determining whether enriched egg consumption can safely improve retina function, while not adversely effecting body composition and cardiovascular risk factors in individuals with diabetes. The results of this study will contribute to the development of valuable prevention strategies for eye health in individuals with diabetes, thereby improving their quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2020
CompletedFirst Posted
Study publicly available on registry
August 3, 2020
CompletedStudy Start
First participant enrolled
July 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedNovember 2, 2023
November 1, 2023
2.1 years
July 24, 2020
November 1, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Retina Function
Measured by Full Field Electroretinography
6 weeks
Study Arms (2)
Enriched Egg Group
EXPERIMENTALParticipants will consume 2 medium sized docosahexaenoic acid and lutein enriched eggs daily (at least 5 days per week) for 6 weeks.
Regular Egg Group
PLACEBO COMPARATORParticipants will consume 2 medium sized non-enriched eggs daily (at least 5 days per week) for 6 weeks.
Interventions
Consumption of 2 docosahexaenoic acid and lutein enriched eggs daily (at least 5 days our week) for 6 weeks
Consumption of 2 non enriched eggs daily (at least 5 days our week) for 6 weeks
Eligibility Criteria
You may qualify if:
- Adults (\>19 years of age)
- Individuals diagnosed with Type 2 diabetes
- Individuals taking oral hypoglycemic medications (sulfonylureas, meglitinides, biguanides, thiazolidinediones etc.)
- Individuals with a fasting plasma glucose of ≥7.0 mmol/L or glycated hemoglobin (A1C) of ≥6.5%. (these values are based on the Canadian Diabetes Association and are predictors of the development of diabetic retinopathy)
You may not qualify if:
- Individuals previously diagnosed with moderate to severe diabetic retinopathy (to assess egg consumption as a preventative strategy for diabetic retinopathy).
- Individuals with eye disease (cataracts, glaucoma, age-related macular degeneration, retinitis pigmentosa, optic atrophy, and eye malformation etc.)
- Individuals with Alzheimer's, dementia or other mental cognitive diseases
- Individuals with Type 1 diabetes
- Individuals taking insulin
- Individuals diagnosed with cancer or anemia
- Pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Manitobalead
- Egg Farmers of Canadacollaborator
Study Sites (1)
Asper Clinical Research Institute
Winnipeg, Manitoba, R2H 2A6, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Miyoung Suh, RD, PhD
University of Manitoba
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2020
First Posted
August 3, 2020
Study Start
July 11, 2022
Primary Completion
September 1, 2024
Study Completion
September 1, 2024
Last Updated
November 2, 2023
Record last verified: 2023-11