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

NCT03771261 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2023-09-11

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Connie Bales, RD, PhD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-15
Primary Completion
2021-11-05
Completion
2021-11-08

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03771261 on ClinicalTrials.gov