Enriched Eggs for Diabetic Retinopathy

Recruiting in Palo Alto (17 mi)

Overseen byMiyoung Suh, RD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Manitoba

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults over 19 with Type 2 diabetes who have a fasting plasma glucose of ≥7.0 mmol/L or A1C of ≥6.5%, and are taking oral hypoglycemic medications. It's not for those with cognitive diseases, eye diseases other than diabetic retinopathy, severe diabetic retinopathy, insulin users, cancer or anemia patients, or pregnant women.

Inclusion Criteria

My blood sugar or A1C levels indicate I might develop diabetic eye disease.

I am taking oral medication for diabetes.

I have been diagnosed with Type 2 diabetes.

+1 more

Exclusion Criteria

I am currently taking insulin.

I have an eye condition like cataracts or glaucoma.

I have been diagnosed with moderate to severe diabetic retinopathy.

+4 more

Participant Groups

The study tests if eating two DHA and lutein enriched eggs daily improves retina health in Type 2 diabetics compared to regular eggs. This double-blinded trial will measure changes in blood lipids, carotenoids, body composition and cardiovascular risk factors after six weeks.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Enriched Egg GroupExperimental Treatment1 Intervention

Participants will consume 2 medium sized docosahexaenoic acid and lutein enriched eggs daily (at least 5 days per week) for 6 weeks.

Group II: Regular Egg GroupPlacebo Group1 Intervention

Participants will consume 2 medium sized non-enriched eggs daily (at least 5 days per week) for 6 weeks.