Recruiting

Enriched Eggs

Sponsor:

University of Manitoba

Code:

NCT04496817

Conditions

Diabetic Retinopathy

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Accepted

Interventions

Docosahexaenoic Acid and Lutein Enriched Eggs

Regular Eggs

Study Details

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.

Conditions

Diabetic Retinopathy

Type 2 Diabetes

Study ID

NCT04496817

Start date

Jul 11, 2022

Status verified date

Nov, 2023

Completion date

Sep 1, 2024

Anticipated

Primary completion date

Sep 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Enriched Egg Group

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

placebo comparator: Regular Egg Group

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

Interventions

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

Primary outcome measure

  • Change in Retina Function [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Locations

Asper Clinical Research Institute

Recruiting

Winnipeg, Manitoba, Canada, R2H 2A6

Contacts

More Information

Sponsor

University of Manitoba

Last update posted

Nov 2, 2023

Last verified

Nov, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by University of Manitoba on 2023-11-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.