Status:
COMPLETED
Balanced (Egg) Protein During Obesity Reduction: Differential Responses of Insulin Resistance by Race
Lead Sponsor:
Duke University
Collaborating Sponsors:
Egg Nutrition Center
Conditions:
Pre Diabetes
Obesity
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
The purpose of the trial is to assess the effects of combining regular, generous intakes of high quality protein (with substantial amounts provided from whole eggs and egg whites) with calorie restric...
Detailed Description
Older (\>60 yrs) men and women (50% African American, 50% white) who are obese (BMI \>30 kg/m2) and have pre-diabetes will be randomly assigned (1:1 ratio; couples randomized together) to one to two t...
Eligibility Criteria
Inclusion
- Age \> 60 years
- Identifies as Caucasian/white or African-American/black
- Obese body weight (\>30 kg/m2)
- Able to speak and understand spoken and written English
- Elevated fasting plasma glucose (≥95 and \<126 mg/dL)
- Age-normal Kidney function (≥ 45 mL/min/1.73 m2)
Exclusion
- Body weight \> 224 kg (limit of the BodPod)
- Treated or untreated diabetes (prior diagnosis, treatment, or fasting blood glucose ≥126 mg/dL)
- Presence of unstable, acutely symptomatic, or life-limiting illness
- Positive screen for dementia using Mini-Cog evaluation tool
- Neurological conditions causing functional or cognitive impairments
- History of significant weight instability (defined as \> 10 pounds weight gain or loss over 6 months prior to study participation)
- Allergy or intolerance to egg products
- Unwillingness or inability to be randomized to any one of two intervention groups, submit to all study testing, or continuously participate in a randomly assigned lifestyle intervention program for four months
- Inability to walk independently
- Unable to give consent
- Unable to complete written recording forms including journals of eating and exercise behaviors.
- Current use of the following medications: monoamine oxidase inhibitors, prescription weight loss medications, insulin, metformin or any other hypoglycemic agent
- Primary Care Physician advises against participation
- Smoker
- Unusually or unstable renal function
Key Trial Info
Start Date :
June 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2021
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT03771261
Start Date
June 15 2018
End Date
November 8 2021
Last Update
September 11 2023
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710