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

Diabetes Mellitus Clinical Trial

Official title: Egg Effects on Atherogenic Dyslipidemia, Glucose Metabolism and Inflammation in Diabetic Subjects

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus
• Dyslipidemias
• Inflammation

• NCT number: NCT02181244
• Study type: Interventional
• Source: University of Connecticut
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Completion date: June 2014