Obesity Clinical Trial
Official title:
Egg Consumption Positively Affects Glycemic Control and Insulin Sensitivity in Individuals With Pre- and Type II-diabetes
Verified date | August 2017 |
Source | Florida State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 42 |
Est. completion date | August 5, 2017 |
Est. primary completion date | September 7, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Florida State University | Tallahassee | Florida |
Lead Sponsor | Collaborator |
---|---|
Florida State University | Egg Nutrition Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Body composition | A certified operator will obtain DXA scans of each subject using DXA (GE Healthcare Lunar, Madison, WI, U.S.). | 12 weeks | |
Other | ABCA1 Protein | ELISA kits will be used to measure the ABCA1 protein (mg/dL) | 12 weeks | |
Primary | 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-ß using the HOMA2 Calculator v2.2.2 | 12 weeks | |
Secondary | Lipid panel | ELISA kits will be used to measure the lipid panel parameters (mg/dL) | 12 weeks |
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