Enriched Eggs for Retina Health in Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Effects of DHA and Lutein Enriched Eggs on Retina Health and Metabolic and Physical Parameters in Type 2 Diabetes: a Strategy for Diabetic Retinopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04496817
• Other study ID #: B2020:007
• Status: Recruiting
• Phase: N/A
• Start date: July 11, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: November 2023
• Source: University of Manitoba
• Contact: Miyoung Suh, RD, PhD
• Phone: 204-235-3106
• Email: miyoung.suh[@]umanitoba.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Retinopathy
• Retinal Diseases
• Type 2 Diabetes

Intervention

Other:
• Docosahexaenoic Acid and Lutein Enriched Eggs
Consumption of 2 docosahexaenoic acid and lutein enriched eggs daily (at least 5 days our week) for 6 weeks
• Regular Eggs
Consumption of 2 non enriched eggs daily (at least 5 days our week) for 6 weeks

Locations

Country	Name	City	State
Canada	Asper Clinical Research Institute	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Egg Farmers of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Retina Function	Measured by Full Field Electroretinography	6 weeks