NCT03771261

Balanced (Egg) Protein During Obesity Reduction: Differential Responses of Insulin Resistance by Race

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pre Diabetes
• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Weight Loss	Participants will be prescribed hypo-caloric diet by a registered dietitian and attend weekly social support/nutrition education meetings.
DIETARY_SUPPLEMENT	Egg Protein	Participants will be provided pre-packaged hard-boiled eggs (3/day, medium) and egg white protein powder.

Timeline

• Start date: 2018-06-15
• Primary completion: 2021-11-05
• Completion: 2021-11-08
• First posted: 2018-12-11
• Last updated: 2023-09-11

Locations

1 site across 1 country: United States