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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.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ManitobaLead Sponsor

595 Previous Clinical Trials

199,421 Total Patients Enrolled

Egg Farmers of CanadaUNKNOWN

2 Previous Clinical Trials

210 Total Patients Enrolled

Miyoung Suh, RD, PhDPrincipal InvestigatorUniversity of Manitoba

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment period open for this experiment?

"Affirmative. Data hosted on clinicaltrials.gov shows that this trial is still open for recruitment, having been first posted on July 11th 2022 and most recently updated November 1st 2022. This study requires 60 participants from a single facility."

Answered by AI

How many people are taking part in the current clinical experiment?

"Affirmative, the information available on clinicaltrials.gov suggests that recruitment is open for this medical trial. It was first published on July 11th 2022 and recently edited on November 1st 2022. 60 participants are necessary to be enrolled from a single health facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Enriched Eggs for Retina Health in Type 2 Diabetes

2022. "Enriched Eggs for Retina Health in Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04496817.

All > Diabetic Retinopathy > Type 2 Diabetes