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Egg Effects on Atherogenic Dyslipidemias, Glucose Metabolism and Inflammation in Diabetic Subjects

NCT02181244 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2014-07-03

No results posted yet for this study

Summary

There is concern in the literature regarding egg consumption in diabetic people. The investigators hypothesis is that compared to an oatmeal-based breakfast, an egg-based breakfast will not increase the risk for heart disease in diabetic people but it may reduce inflammation, in this population characterized by chronic low grade inflammation.

This is a cross-over study in which subjects will be randomly allocated to consume 1 egg per day for breakfast or a bowl of oatmeal with lactose-free milk for 5 weeks. After a 3 wk washout period, subjects will be allocated to the alternate treatment for additional 5 weeks.

Blood will be collected at baseline and at the end of each dietary period to measure plasma lipids, glucose, insulin, glycosylated hemoglobin and inflammatory markers.

Conditions

Interventions

OTHER

Egg, one a day, for breakfast

One egg per day as breakfast for 5 weeks followed by a 3 week washout period and 5 additional weeks on oatmeal. This is a randomized crossover design. Half of subjects started with the eggs and the other half with oatmeal. Blood lipids, glucose and inflammatory measurements will be finished 24. weeks after completion of the study. Data will be reported 1 year after the completion of the study.

OTHER

Oatmeal, one cup a day

Subjects will be fed oatmeal for a period of 5 weeks. After 3 weeks they will be switched to the alternate diet. This is a randomized control trail in which plasma glucose, plasma lipids and inflammatory markers will be measured. All these measurements will be finished 24 weeks after completion of the study. Data will be reported after 1 year of the completion of the study.

Sponsors & Collaborators

  • University of Connecticut

    lead OTHER

Principal Investigators

  • Maria-Luz Fernandez, PhD · University of Connecticut

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-01-31
Completion
2014-06-30

Countries

  • Mexico

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02181244 on ClinicalTrials.gov