Clinical trial NCT02181244: Egg Effects on Atherogenic Dyslipidemias, Glucose Metabolism and Inflammation in Diabetic Subjects
Official title: Egg Effects on Atherogenic Dyslipidemia, Glucose Metabolism and Inflammation in Diabetic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Inflammation
Keywords: egg
oatmeal
atherogenic dyslipidemia
glycosylated hemoglobin
inflammatory markers
Lead sponsor: University of Connecticut
Sponsor class: OTHER
First posted: 2014-07-03
Enrollment: 33
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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

Eligibility criteria: 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

Primary outcomes:
measure: glycosylated hemoglobin
timeFrame: 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
Secondary outcomes:
measure: plasma LDL cholesterol
timeFrame: Measured at baseline and 5 weeks after the consuming the eggs and 5 weeks after consuming the oatmeal
Other outcomes:
measure: tumor necrosis factor alpha
timeFrame: Assessed after 5 weeks of consuming the eggs and after 5 weeks of consuming the oatmeal
Locations:
city: Hermosillo
country: Mexico
facility: Centro de Investigacion y Desarrollo
state: Sonora
Study officials:
affiliation: University of Connecticut
name: Maria-Luz Fernandez, PhD
role: PRINCIPAL_INVESTIGATOR
References: