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

Primary Purpose

Diabetes Mellitus, Inflammation

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Egg, one a day, for breakfast
Oatmeal, one cup a day
Sponsored by
University of Connecticut
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes Mellitus focused on measuring egg, oatmeal, atherogenic dyslipidemia, glycosylated hemoglobin, inflammatory markers

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centro de Investigacion y Desarrollo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Egg, one a day, for breakfast

Oatmeal, one cup a day

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

glycosylated hemoglobin
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
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.

Full Information

First Posted
June 20, 2014
Last Updated
July 1, 2014
Sponsor
University of Connecticut
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1. Study Identification

Unique Protocol Identification Number
NCT02181244
Brief Title
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

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Connecticut

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Inflammation
Keywords
egg, oatmeal, atherogenic dyslipidemia, glycosylated hemoglobin, inflammatory markers

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Egg, one a day, for breakfast
Arm Type
Experimental
Arm Description
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.
Arm Title
Oatmeal, one cup a day
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Egg, one a day, for breakfast
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Oatmeal, one cup a day
Intervention Description
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 Outcome Measure Information:
Title
glycosylated hemoglobin
Description
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.
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
Secondary Outcome Measure Information:
Title
plasma LDL cholesterol
Description
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.
Time Frame
Measured at baseline and 5 weeks after the consuming the eggs and 5 weeks after consuming the oatmeal
Other Pre-specified Outcome Measures:
Title
tumor necrosis factor alpha
Description
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.
Time Frame
Assessed after 5 weeks of consuming the eggs and after 5 weeks of consuming the oatmeal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria-Luz Fernandez, PhD
Organizational Affiliation
University of Connecticut
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Investigacion y Desarrollo
City
Hermosillo
State/Province
Sonora
Country
Mexico

12. IPD Sharing Statement

Learn more about this trial

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

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