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Enriched Eggs for Retina Health in Type 2 Diabetes

Primary Purpose

Diabetic Retinopathy, Type 2 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Docosahexaenoic Acid and Lutein Enriched Eggs
Regular Eggs
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetic Retinopathy

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Asper Clinical Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Enriched Egg Group

Regular Egg Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Retina Function
Measured by Full Field Electroretinography

Secondary Outcome Measures

Full Information

First Posted
July 24, 2020
Last Updated
November 1, 2022
Sponsor
University of Manitoba
Collaborators
Egg Farmers of Canada
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1. Study Identification

Unique Protocol Identification Number
NCT04496817
Brief Title
Enriched Eggs for Retina Health in Type 2 Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba
Collaborators
Egg Farmers of Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy, Type 2 Diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double-blinded, randomized, placebo-controlled, parallel trial.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enriched Egg Group
Arm Type
Experimental
Arm Description
Participants will consume 2 medium sized docosahexaenoic acid and lutein enriched eggs daily (at least 5 days per week) for 6 weeks.
Arm Title
Regular Egg Group
Arm Type
Placebo Comparator
Arm Description
Participants will consume 2 medium sized non-enriched eggs daily (at least 5 days per week) for 6 weeks.
Intervention Type
Other
Intervention Name(s)
Docosahexaenoic Acid and Lutein Enriched Eggs
Intervention Description
Consumption of 2 docosahexaenoic acid and lutein enriched eggs daily (at least 5 days our week) for 6 weeks
Intervention Type
Other
Intervention Name(s)
Regular Eggs
Intervention Description
Consumption of 2 non enriched eggs daily (at least 5 days our week) for 6 weeks
Primary Outcome Measure Information:
Title
Change in Retina Function
Description
Measured by Full Field Electroretinography
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miyoung Suh, RD, PhD
Phone
204-235-3106
Email
miyoung.suh@umanitoba.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Chelsey Walchuk, RD, MSc
Phone
204-235-2573
Email
umwalchu@myumanitoba.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miyoung Suh, RD, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asper Clinical Research Institute
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaime Clark, PhD
Phone
204-25-1351
Email
jclark@sbrc.ca

12. IPD Sharing Statement

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Enriched Eggs for Retina Health in Type 2 Diabetes

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