NCT03771261

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 11, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2021

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2021

Completed
Last Updated

September 11, 2023

Status Verified

January 1, 2022

Enrollment Period

3.4 years

First QC Date

November 21, 2018

Last Update Submit

September 7, 2023

Conditions

Pre DiabetesObesity

Keywords

EggProteinAgingHealth DisparitiesWeight Loss

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline Insulin Resistance at 4 months

    Blood glucose and insulin levels in whole blood will be used to compute HOMA-IR (= glucose mg/dL x insulin mg/dL/405)

    0 to 4 months

  • Change from Baseline Body weight at 4 months

    Weight loss as measured in light clothing on a dedicated scale.

    0 to 4 months

Secondary Outcomes (22)

  • Change from baseline Short Physical Performance Battery at 4 months

    0 to 4 months

  • Change from baseline 6-minute walk (meters) at 4 months

    0 to 4 months

  • Change from baseline 8-foot up and Go time at 4 months

    0 to 4 months

  • Change from baseline 30-second chair stands (number of stands) at 4 months

    0 to 4 months

  • Change from baseline handgrip strength at 4 months

    0 to 4 months

  • +17 more secondary outcomes

Study Arms (2)

WL-Control

PLACEBO COMPARATOR

Weight loss intervention (WL-Control; n = 20): Subjects follow a calorie-reduction diet for a weight loss of ≥10%, protein\~0.8g/g/d.

Behavioral: Weight Loss

WL-Protein

ACTIVE COMPARATOR

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 at each meal. Intakes of \> 30g of protein will be achieved three times a day by subjects in this group, with all or predominantly all from animal sources (high quality) and 60-70% of animal protein from eggs or egg protein powder that will be provided to WL-Protein participants.

Behavioral: Weight LossDietary Supplement: Egg Protein

Interventions

Weight LossBEHAVIORAL

Participants will be prescribed hypo-caloric diet by a registered dietitian and attend weekly social support/nutrition education meetings.

WL-ControlWL-Protein
Egg ProteinDIETARY_SUPPLEMENT

Participants will be provided pre-packaged hard-boiled eggs (3/day, medium) and egg white protein powder.

WL-Protein

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (3)

  • Porter Starr KN, McDonald SR, Bales CW. Obesity and physical frailty in older adults: a scoping review of lifestyle intervention trials. J Am Med Dir Assoc. 2014 Apr;15(4):240-50. doi: 10.1016/j.jamda.2013.11.008. Epub 2014 Jan 17.

    PMID: 24445063BACKGROUND

  • Porter Starr KN, Pieper CF, Orenduff MC, McDonald SR, McClure LB, Zhou R, Payne ME, Bales CW. Improved Function With Enhanced Protein Intake per Meal: A Pilot Study of Weight Reduction in Frail, Obese Older Adults. J Gerontol A Biol Sci Med Sci. 2016 Oct;71(10):1369-75. doi: 10.1093/gerona/glv210. Epub 2016 Jan 18.

    PMID: 26786203BACKGROUND

  • Porter Starr KN, McDonald SR, Weidner JA, Bales CW. Challenges in the Management of Geriatric Obesity in High Risk Populations. Nutrients. 2016 May 4;8(5):262. doi: 10.3390/nu8050262.

    PMID: 27153084BACKGROUND

Related Links

MeSH Terms

Conditions

Glucose IntoleranceObesityWeight Loss

Interventions

Egg Proteins

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

ProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Connie Bales, RD, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2018

First Posted

December 11, 2018

Study Start

June 15, 2018

Primary Completion

November 5, 2021

Study Completion

November 8, 2021

Last Updated

September 11, 2023

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)