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NCT Number: NCT02181244

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

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Inflammation Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Investigacion y Desarrollo

Hermosillo, Sonora, Mexico

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Egg, one a day, for breakfast

Other

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.

Oatmeal, one cup a day

Other

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.

Primary outcomes

  1. glycosylated hemoglobin

    Time frame: 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 outcomes

  1. plasma LDL cholesterol

    Time frame: 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.

Other outcomes

  1. tumor necrosis factor alpha

    Time frame: Assessed after 5 weeks of consuming the eggs and after 5 weeks of consuming the oatmeal

    This parameter was measured to determine whether egg intake favorably would affect inflammation in diabetic subjects. Tumor necrosis factor alpha was measured after 5 weeks of consuming the eggs and 5 weeks after consuming the oatmeal.

Sponsors and collaborators

Lead sponsor

University of Connecticut

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 3, 2014
Registry last updated
Jul 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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