Ignite Creation Date:
2025-12-24 @ 12:49 PM
Ignite Modification Date:
2026-02-20 @ 3:33 PM
Study NCT ID:
NCT03771261
Status:
COMPLETED
Last Update Posted:
2023-09-11
First Post:
2018-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Balanced (Egg) Protein During Obesity Reduction: Differential Responses of Insulin Resistance by Race
Sponsor:
Duke University
Organization:
Study Overview
Official Title:
Balanced (Egg) Protein During Obesity Reduction: Differential Responses of Insulin Resistance by Race
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EGGSPDITe
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 restriction on insulin resistance and weight loss (along with function, body composition, racial disparities, and a number of secondary outcomes) in black and white older adults with prediabetes who are participating in a 4-month intervention. The investigators will compare these effects to the same outcomes with a control group consuming a traditional control regimen of calorie restriction over the same duration.
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 treatment groups: 1) Weight loss intervention (WL-Control; n = 20): subjects follow a calorie-reduction diet for a weight loss of ≥10%, protein\~0.8g/g/d; and 2) High protein weight loss intervention (WL-Protein; n = 20): subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of high quality protein (\> 30g protein, 3/day, 60-70% egg protein). Primary (insulin resistance/sensitivity, weight loss) and secondary outcomes (physical function, body composition, diet adherence, cognitive function, readiness to change) will be measured at 0 and 4 months.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: