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Nutritional Supplement
Enriched Eggs for Diabetic Retinopathy
N/A
Recruiting
Led By Miyoung Suh, RD, PhD
Research Sponsored by University of Manitoba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Individuals taking oral hypoglycemic medications (sulfonylureas, meglitinides, biguanides, thiazolidinediones etc.)
Must not have
Individuals taking insulin
Individuals with eye disease (cataracts, glaucoma, age-related macular degeneration, retinitis pigmentosa, optic atrophy, and eye malformation etc.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Summary
This trialaims to assess if eating two DHA & lutein enriched eggs a day can improve eye health in those with diabetes, without impacting body composition & cardiovascular risk.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include changes to cholesterol levels due to egg consumption; however specific side effects related to the enriched eggs aren't detailed but could be similar to regular egg consumption.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood sugar or A1C levels indicate I might develop diabetic eye disease.
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I am taking oral medication for diabetes.
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I have been diagnosed with Type 2 diabetes.
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I am over 19 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking insulin.
Select...
I have an eye condition like cataracts or glaucoma.
Select...
I have been diagnosed with moderate to severe diabetic retinopathy.
Select...
I have been diagnosed with cancer or anemia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Retina Function
Trial Design
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.
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Who is running the clinical trial?
University of ManitobaLead Sponsor
620 Previous Clinical Trials
206,721 Total Patients Enrolled
Egg Farmers of CanadaUNKNOWN
2 Previous Clinical Trials
205 Total Patients Enrolled
Miyoung Suh, RD, PhDPrincipal InvestigatorUniversity of Manitoba
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