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

Not Applicable

Completed

• Conditions: Diabetes Mellitus; Inflammation

• Registration Number: NCT02181244
• Lead Sponsor: University of Connecticut

Brief 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.

Detailed Description

This study is conducted in diabetic patients who are given two distinct breakfasts: eggs and oatmeal in a crossover design. The investigators hypothesis is that eggs will not increase the risk for heart disease in this population when compared to oatmeal but they will more likely reduce inflammation due to the presence of the carotenoids, lutein and zeaxanthin that are highly available in eggs.

In this study, the investigators are evaluating three main things

* Atherogenic dyslipidemia by measuring plasma lipids and lipoprotein mean size and subfractions by nuclear magnetic resonance.

* Glucose metabolism by measuring plasma glucose, insulin, insulin resistance and glycosylated hemoglobin.

* Inflammation by measuring liver enzymes, C reactive protein, tumor necrosis factor-alpha, interleukin-6.

All these measurements were done 24 weeks after completion of the study All data will be presented 1 year after completion of the study

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2014-01
• Study Completion: 2014-06
• Study First Submitted: 2014-06-20
• Status Verified: 2014-07
• Study First Submitted QC: 2014-07-01
• Last Update Submitted: 2014-07-01
• Study First Posted: 2014-07-03
• Last Update Posted: 2014-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• diabetic subjects diagnosed by physician
• male and female
• 35-65 years
• Glycosylated hemoglobin < 9%

Exclusion Criteria

• taking ezetimibe
• heart disease
• renal problems
• cancer
• thyroid problems

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
glycosylated hemoglobin	Assessed at base line and at the end of 5 weeks after the consumption of eggs and at the end of 5 weeks after the consumption of oatmeal	Glycosylated hemoglobin had to be \< 9% as one of the inclusion criteria. This parameter was assessed after 5 weeks that the subjects consumed the egg and after 5 weeks after the subjects were consuming the oatmeal.

Secondary Outcome Measures

Name	Time	Method
plasma LDL cholesterol	Measured at baseline and 5 weeks after the consuming the eggs and 5 weeks after consuming the oatmeal	This parameter was assessed to ensure that no significant changes in LDL cholesterol occurred by egg intake or oatmeal intake. LDL cholesterol was assessed after 5 weeks of consuming the eggs and 5 weeks of consuming the oatmeal.

Trial Locations

Locations (1)

Centro de Investigacion y Desarrollo; 🇲🇽 Hermosillo, Sonora, Mexico