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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Connecticut
ClinicalTrials.gov Identifier:
NCT02181244
First received: June 20, 2014
Last updated: July 1, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Inflammation
Other: Egg, one a day, for breakfast
Other: Oatmeal, one cup a day

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Egg Effects on Atherogenic Dyslipidemia, Glucose Metabolism and Inflammation in Diabetic Subjects

Further study details as provided by University of Connecticut:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Enrollment: 33
Study Start Date: May 2013
Study Completion Date: June 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Egg, one a day, for breakfast
The intervention consists in feeding the subjects egg, one a day for breakfast during 5 weeks. At the end of the intervention, blood will be obtained to measure plasma lipids, glucose, insulin and inflammatory markers. All measurements will be finished 24 weeks after the intervention is finished. All data will be reported 1 year after completion of the study.
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.
Experimental: Oatmeal, one cup a day
In this arm, subjects will consume oatmeal for a period of 5 weeks. Blood samples will be taken and different parameters will be measured including plasma lipids, glucose, insulin and inflammatory markers. All these measurements will be finished 24 weeks after completion of the study. All data will be reported 1 year after completion of the study.
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.

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

Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02181244

Locations
Mexico
Centro de Investigacion y Desarrollo
Hermosillo, Sonora, Mexico
Sponsors and Collaborators
University of Connecticut
Investigators
Principal Investigator: Maria-Luz Fernandez, PhD University of Connecticut
  More Information

Responsible Party: University of Connecticut
ClinicalTrials.gov Identifier: NCT02181244     History of Changes
Other Study ID Numbers: H12-059
Study First Received: June 20, 2014
Last Updated: July 1, 2014

Keywords provided by University of Connecticut:
egg
oatmeal
atherogenic dyslipidemia
glycosylated hemoglobin
inflammatory markers

Additional relevant MeSH terms:
Diabetes Mellitus
Inflammation
Dyslipidemias
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on March 29, 2017