Egg Consumption and Glycemic Control in Individuals With Pre- and Type II-diabetes
Primary Purpose
Diabetes Mellitus, Type 2, Obesity, Pre Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Egg and egg white
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- Overweight and obese, BMI is between 25 kg/m2 and 45 kg/m2
- With pre- and type II-diabetes. Subjects will be eligible if their Hgb A1c level is >5.6%
Exclusion Criteria:
- Subjects with BMI≤ 24 or ≥46 kg/m2
- Uncontrolled hypertension (≥160/100 mmHg), active cancer, asthma, thyroid, glaucoma, kidney, liver and pancreatic diseases will be excluded from the study.
- Subjects who are participating in any weight loss program and/or are heavy smokers (more than 20 cigarettes per day) will be excluded from the study.
- Subjects who are allergic to egg and egg products will also be excluded from the study.
Sites / Locations
- Florida State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Egg Group (Group A)
Egg White Group (Group B)
Arm Description
Participants will consume one large egg per day for 12 weeks
Participants will consume equivalent amounts of egg whites for 12 weeks
Outcomes
Primary Outcome Measures
Fasting blood glucose, insulin resistance, and insulin sensitivity
Commercially available enzyme-linked immunosorbent assay (ELISA) kits will be used to measure fasting blood glucose levels (mg/dL.). Insulin levels will be measured using a commercially available ELISA kit (mg/dL). blood glucose and insulin level measurements will be used to calculate Insulin sensitivity and insulin resistance will be measured using HOMA-IR and HOMA-β using the HOMA2 Calculator v2.2.2
Secondary Outcome Measures
Lipid panel
ELISA kits will be used to measure the lipid panel parameters (mg/dL)
Full Information
NCT ID
NCT03272074
First Posted
August 28, 2017
Last Updated
August 31, 2017
Sponsor
Florida State University
Collaborators
Egg Nutrition Center
1. Study Identification
Unique Protocol Identification Number
NCT03272074
Brief Title
Egg Consumption and Glycemic Control in Individuals With Pre- and Type II-diabetes
Official Title
Egg Consumption Positively Affects Glycemic Control and Insulin Sensitivity in Individuals With Pre- and Type II-diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 11, 2015 (Actual)
Primary Completion Date
September 7, 2016 (Actual)
Study Completion Date
August 5, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University
Collaborators
Egg Nutrition Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The intent of this study is to examine the extent to which daily incorporation of egg into a diet improves glycemic control, insulin sensitivity, lipid profiles, and body composition in overweight and obese adults with pre- and type II-diabetes. The hypothesis of this study is that the daily incorporation of one large egg into a diet for 12 weeks will exert positive effects on factors associated with glycemic control and insulin sensitivity in overweight and obese adults with pre- and type II-diabetes through improvements in body weight, body composition, and lipid metabolism.
Detailed Description
Pre-diabetes is a condition that is characterized by elevated fasting blood glucose levels secondary to insulin resistance; however, fasting blood glucose levels are not elevated to the extent where it can be classified as type II-diabetes. Pre-diabetes may lead to type II-diabetes and is estimated to do so at an annual rate of approximately 10% in the United States (US) where approximately 79 million individuals have been diagnosed with pre-diabetes. In addition, most of the individuals presenting with pre-diabetes are overweight or obese, which makes long-term weight management an essential component in reducing the development of diabetes. Eggs are a rich source of important nutrients such as vitamins, minerals, proteins, carotenoids, choline, and lecithin. Many of the nutrients found in eggs function as antioxidants or as an essential component of antioxidants. Several studies have demonstrated that the onset and progression of diabetes are associated with increased oxidative stress. In vitro studies have shown that high-density lipoprotein (HDL) acts as a buffer mechanism for oxidative stress and inflammation due to its antioxidant effects. Thus, high blood levels of HDL may reduce insulin resistance and subsequently the development of type II-diabetes through its antioxidant and anti-inflammatory effects. Additionally, HDL can exert beneficial effects on glucose levels through the apolipoprotein A-1 (Apo A) action which increases glucose uptake by increasing insulin secretion in pancreatic beta cells. Because the development of diabetes involves an interaction between genetic predisposition and environmental factors including and excessive body weight, and eggs have been shown to positively influence body composition, we believe that eggs can improve glycemic control, insulin sensitivity, and lipid profiles through improvements in weight and body composition. To our knowledge, there have not been any studies investigating the effects of dietary egg consumption on improving glycemic control, insulin sensitivity, lipid profiles, and body composition in overweight and obese adults with pre- and type II-diabetics. Our long-term goal is to bring forth evidence that the regular consumption of eggs is effective in reducing insulin resistance and subsequently the incidence of pre-diabetes and type II-diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Obesity, Pre Diabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Egg Group (Group A)
Arm Type
Experimental
Arm Description
Participants will consume one large egg per day for 12 weeks
Arm Title
Egg White Group (Group B)
Arm Type
Active Comparator
Arm Description
Participants will consume equivalent amounts of egg whites for 12 weeks
Intervention Type
Other
Intervention Name(s)
Egg and egg white
Intervention Description
Participants will consume either one large eggs or equivalent amount of egg white (3/4 cups) for 12 weeks. Participants will maintain their regular diet and physical activities.
Primary Outcome Measure Information:
Title
Fasting blood glucose, insulin resistance, and insulin sensitivity
Description
Commercially available enzyme-linked immunosorbent assay (ELISA) kits will be used to measure fasting blood glucose levels (mg/dL.). Insulin levels will be measured using a commercially available ELISA kit (mg/dL). blood glucose and insulin level measurements will be used to calculate Insulin sensitivity and insulin resistance will be measured using HOMA-IR and HOMA-β using the HOMA2 Calculator v2.2.2
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Lipid panel
Description
ELISA kits will be used to measure the lipid panel parameters (mg/dL)
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Body composition
Description
A certified operator will obtain DXA scans of each subject using DXA (GE Healthcare Lunar, Madison, WI, U.S.).
Time Frame
12 weeks
Title
ABCA1 Protein
Description
ELISA kits will be used to measure the ABCA1 protein (mg/dL)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Overweight and obese, BMI is between 25 kg/m2 and 45 kg/m2
With pre- and type II-diabetes. Subjects will be eligible if their Hgb A1c level is >5.6%
Exclusion Criteria:
Subjects with BMI≤ 24 or ≥46 kg/m2
Uncontrolled hypertension (≥160/100 mmHg), active cancer, asthma, thyroid, glaucoma, kidney, liver and pancreatic diseases will be excluded from the study.
Subjects who are participating in any weight loss program and/or are heavy smokers (more than 20 cigarettes per day) will be excluded from the study.
Subjects who are allergic to egg and egg products will also be excluded from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shirin Pourafshar, PhD
Organizational Affiliation
Florida State University
Official's Role
Study Director
Facility Information:
Facility Name
Florida State University
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Egg Consumption and Glycemic Control in Individuals With Pre- and Type II-diabetes
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