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

Primary Purpose

Pre Diabetes, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight Loss
Egg Protein
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pre Diabetes focused on measuring Egg, Protein, Aging, Health Disparities, Weight Loss

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 Criteria:

  • 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

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

WL-Control

WL-Protein

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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)
Change from Baseline Body weight at 4 months
Weight loss as measured in light clothing on a dedicated scale.

Secondary Outcome Measures

Change from baseline Short Physical Performance Battery at 4 months
Physical Performance as measured by Short Physical Performance Battery (SPPB)
Change from baseline 6-minute walk (meters) at 4 months
Distance (meters) walked in 6 minutes
Change from baseline 8-foot up and Go time at 4 months
Time it takes to get up from a chair walk around a cone and sit back down (8-foot up and go)
Change from baseline 30-second chair stands (number of stands) at 4 months
the number of chair stands completed in 30 seconds
Change from baseline handgrip strength at 4 months
the highest weight achieved from 2 attempts using the JAMAR dynamometer
Change from baseline grooved pegboard time at 4 months
measure of hand dexterity, time it takes to fit pegs into grooved pegboard
Change from baseline fat mass (%) at 4 months
Body fat mass (%) as measured by Bodpod
Change from baseline fat mass (kgs) at 4 months
Body fat mass (kg) as measured by Bodpod
Change from baseline lean mass (kgs) at 4 months
Body lean mass (kg) as measured by Bodpod
Change from baseline lean mass (%) at 4 months
Body lean mass (%) as measured by Bodpod
Change from baseline minimal waist circumference at 4 months
Body proportions will be measured at the minimal waist using a Gulick II tape measure with the tape placed directly on the skin (not over the clothing). Measurements will be taken once at each location before completing a second measurement, and an average of the two will be recorded. A third measurement will be taken if the first two measurements are > 0.5 cm.
Change from baseline umbilical waist circumference at 4 months
Body proportions will be measured at the umbilical waist using a Gulick II tape measure with the tape placed directly on the skin (not over the clothing). Measurements will be taken once at each location before completing a second measurement, and an average of the two will be recorded. A third measurement will be taken if the first two measurements are > 0.5 cm.
Change from baseline hip circumference at 4 months
Body proportions will be measured at the hip using a Gulick II tape measure with the tape placed directly on the skin (not over the clothing). Measurements will be taken once at each location before completing a second measurement, and an average of the two will be recorded. A third measurement will be taken if the first two measurements are > 0.5 cm.
Change from baseline total calories at 4 months
Total calories will be measured using 3-day food records (participants record everything they eat and drink for three days)
Change from baseline macronutrient intake at 4 months
Macronutrient intake will be measured using 3-day food records (participants record everything they eat and drink for three days)
Change from baseline micronutrient intake at 4 months
Micronutrient intake will be measured using 3-day food records (participants record everything they eat and drink for three days)
Change from baseline Symbol digit modalities test at 4 months
Symbol Digit Modalities Test measures cognitive impairment
Change from baseline Trail Making Test at 4 months
Trail Making Test neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy.
Change from baseline Hopkins Verbal Learning Test at 4 months
Hopkins Verbal Learning Test consists of three trials of free-recall of a 12-item, semantically categorized list, followed by yes/no recognition.
Change from baseline Profile of Mood States at 4 months
Profile of Mood States is a psychological rating scale used to assess transient, distinct mood states that uses a five-point scale ranging from "not at all" to "extremely".
Change from baseline Perceived Stress Scale at 4 months
Perceived Stress Scale is a a 12-item stress assessment instrument. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Change from Baseline Insulin Sensitivity at 4 months
insulin sensitivity HOMA-β (= 360 x insulin mg/dL / glucose mg/dL - 63; %).

Full Information

First Posted
November 21, 2018
Last Updated
September 7, 2023
Sponsor
Duke University
Collaborators
Egg Nutrition Center
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1. Study Identification

Unique Protocol Identification Number
NCT03771261
Brief Title
Balanced (Egg) Protein During Obesity Reduction: Differential Responses of Insulin Resistance by Race
Acronym
EGGSPDITe
Official Title
Balanced (Egg) Protein During Obesity Reduction: Differential Responses of Insulin Resistance by Race
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
November 5, 2021 (Actual)
Study Completion Date
November 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Egg Nutrition Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre Diabetes, Obesity
Keywords
Egg, Protein, Aging, Health Disparities, Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WL-Control
Arm Type
Placebo Comparator
Arm Description
Weight loss intervention (WL-Control; n = 20): Subjects follow a calorie-reduction diet for a weight loss of ≥10%, protein~0.8g/g/d.
Arm Title
WL-Protein
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Weight Loss
Intervention Description
Participants will be prescribed hypo-caloric diet by a registered dietitian and attend weekly social support/nutrition education meetings.
Intervention Type
Dietary Supplement
Intervention Name(s)
Egg Protein
Intervention Description
Participants will be provided pre-packaged hard-boiled eggs (3/day, medium) and egg white protein powder.
Primary Outcome Measure Information:
Title
Change from Baseline Insulin Resistance at 4 months
Description
Blood glucose and insulin levels in whole blood will be used to compute HOMA-IR (= glucose mg/dL x insulin mg/dL/405)
Time Frame
0 to 4 months
Title
Change from Baseline Body weight at 4 months
Description
Weight loss as measured in light clothing on a dedicated scale.
Time Frame
0 to 4 months
Secondary Outcome Measure Information:
Title
Change from baseline Short Physical Performance Battery at 4 months
Description
Physical Performance as measured by Short Physical Performance Battery (SPPB)
Time Frame
0 to 4 months
Title
Change from baseline 6-minute walk (meters) at 4 months
Description
Distance (meters) walked in 6 minutes
Time Frame
0 to 4 months
Title
Change from baseline 8-foot up and Go time at 4 months
Description
Time it takes to get up from a chair walk around a cone and sit back down (8-foot up and go)
Time Frame
0 to 4 months
Title
Change from baseline 30-second chair stands (number of stands) at 4 months
Description
the number of chair stands completed in 30 seconds
Time Frame
0 to 4 months
Title
Change from baseline handgrip strength at 4 months
Description
the highest weight achieved from 2 attempts using the JAMAR dynamometer
Time Frame
0 to 4 months
Title
Change from baseline grooved pegboard time at 4 months
Description
measure of hand dexterity, time it takes to fit pegs into grooved pegboard
Time Frame
0 to 4 months
Title
Change from baseline fat mass (%) at 4 months
Description
Body fat mass (%) as measured by Bodpod
Time Frame
0 to 4 months
Title
Change from baseline fat mass (kgs) at 4 months
Description
Body fat mass (kg) as measured by Bodpod
Time Frame
0 to 4 months
Title
Change from baseline lean mass (kgs) at 4 months
Description
Body lean mass (kg) as measured by Bodpod
Time Frame
0 to 4 months
Title
Change from baseline lean mass (%) at 4 months
Description
Body lean mass (%) as measured by Bodpod
Time Frame
0 to 4 months
Title
Change from baseline minimal waist circumference at 4 months
Description
Body proportions will be measured at the minimal waist using a Gulick II tape measure with the tape placed directly on the skin (not over the clothing). Measurements will be taken once at each location before completing a second measurement, and an average of the two will be recorded. A third measurement will be taken if the first two measurements are > 0.5 cm.
Time Frame
0 to 4 months
Title
Change from baseline umbilical waist circumference at 4 months
Description
Body proportions will be measured at the umbilical waist using a Gulick II tape measure with the tape placed directly on the skin (not over the clothing). Measurements will be taken once at each location before completing a second measurement, and an average of the two will be recorded. A third measurement will be taken if the first two measurements are > 0.5 cm.
Time Frame
0 to 4 months
Title
Change from baseline hip circumference at 4 months
Description
Body proportions will be measured at the hip using a Gulick II tape measure with the tape placed directly on the skin (not over the clothing). Measurements will be taken once at each location before completing a second measurement, and an average of the two will be recorded. A third measurement will be taken if the first two measurements are > 0.5 cm.
Time Frame
0 to 4 months
Title
Change from baseline total calories at 4 months
Description
Total calories will be measured using 3-day food records (participants record everything they eat and drink for three days)
Time Frame
0 to 4 months
Title
Change from baseline macronutrient intake at 4 months
Description
Macronutrient intake will be measured using 3-day food records (participants record everything they eat and drink for three days)
Time Frame
0 to 4 months
Title
Change from baseline micronutrient intake at 4 months
Description
Micronutrient intake will be measured using 3-day food records (participants record everything they eat and drink for three days)
Time Frame
0 to 4 months
Title
Change from baseline Symbol digit modalities test at 4 months
Description
Symbol Digit Modalities Test measures cognitive impairment
Time Frame
0 to 4 months
Title
Change from baseline Trail Making Test at 4 months
Description
Trail Making Test neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy.
Time Frame
0 to 4 months
Title
Change from baseline Hopkins Verbal Learning Test at 4 months
Description
Hopkins Verbal Learning Test consists of three trials of free-recall of a 12-item, semantically categorized list, followed by yes/no recognition.
Time Frame
0 to 4 months
Title
Change from baseline Profile of Mood States at 4 months
Description
Profile of Mood States is a psychological rating scale used to assess transient, distinct mood states that uses a five-point scale ranging from "not at all" to "extremely".
Time Frame
0 to 4 months
Title
Change from baseline Perceived Stress Scale at 4 months
Description
Perceived Stress Scale is a a 12-item stress assessment instrument. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Time Frame
0 to 4 months
Title
Change from Baseline Insulin Sensitivity at 4 months
Description
insulin sensitivity HOMA-β (= 360 x insulin mg/dL / glucose mg/dL - 63; %).
Time Frame
0 to 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Connie Bales, RD, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24445063
Citation
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.
Results Reference
background
PubMed Identifier
26786203
Citation
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.
Results Reference
background
PubMed Identifier
27153084
Citation
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.
Results Reference
background
Links:
URL
https://medschool.duke.edu/
Description
Duke University School of Medicine
URL
https://www.eggnutritioncenter.org/
Description
Egg Nutrition Center

Learn more about this trial

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

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