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Completed

NCT Number: NCT03771261

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

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.

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Key information

Conditions

Pre Diabetes Body Weight Body Weight Changes Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weight Loss

Behavioral

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

Egg Protein

Dietary Supplement

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

Primary outcomes

  1. Change from Baseline Insulin Resistance at 4 months

    Time frame: 0 to 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)

  2. Change from Baseline Body weight at 4 months

    Time frame: 0 to 4 months

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

Secondary outcomes

  1. Change from baseline Short Physical Performance Battery at 4 months

    Time frame: 0 to 4 months

    Physical Performance as measured by Short Physical Performance Battery (SPPB)

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

    Time frame: 0 to 4 months

    Distance (meters) walked in 6 minutes

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

    Time frame: 0 to 4 months

    Time it takes to get up from a chair walk around a cone and sit back down (8-foot up and go)

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

    Time frame: 0 to 4 months

    the number of chair stands completed in 30 seconds

  5. Change from baseline handgrip strength at 4 months

    Time frame: 0 to 4 months

    the highest weight achieved from 2 attempts using the JAMAR dynamometer

  6. Change from baseline grooved pegboard time at 4 months

    Time frame: 0 to 4 months

    measure of hand dexterity, time it takes to fit pegs into grooved pegboard

  7. Change from baseline fat mass (%) at 4 months

    Time frame: 0 to 4 months

    Body fat mass (%) as measured by Bodpod

  8. Change from baseline fat mass (kgs) at 4 months

    Time frame: 0 to 4 months

    Body fat mass (kg) as measured by Bodpod

  9. Change from baseline lean mass (kgs) at 4 months

    Time frame: 0 to 4 months

    Body lean mass (kg) as measured by Bodpod

  10. Change from baseline lean mass (%) at 4 months

    Time frame: 0 to 4 months

    Body lean mass (%) as measured by Bodpod

  11. Change from baseline minimal waist circumference at 4 months

    Time frame: 0 to 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.

  12. Change from baseline umbilical waist circumference at 4 months

    Time frame: 0 to 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.

  13. Change from baseline hip circumference at 4 months

    Time frame: 0 to 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.

  14. Change from baseline total calories at 4 months

    Time frame: 0 to 4 months

    Total calories will be measured using 3-day food records (participants record everything they eat and drink for three days)

  15. Change from baseline macronutrient intake at 4 months

    Time frame: 0 to 4 months

    Macronutrient intake will be measured using 3-day food records (participants record everything they eat and drink for three days)

  16. Change from baseline micronutrient intake at 4 months

    Time frame: 0 to 4 months

    Micronutrient intake will be measured using 3-day food records (participants record everything they eat and drink for three days)

  17. Change from baseline Symbol digit modalities test at 4 months

    Time frame: 0 to 4 months

    Symbol Digit Modalities Test measures cognitive impairment

  18. Change from baseline Trail Making Test at 4 months

    Time frame: 0 to 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.

  19. Change from baseline Hopkins Verbal Learning Test at 4 months

    Time frame: 0 to 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.

  20. Change from baseline Profile of Mood States at 4 months

    Time frame: 0 to 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".

  21. Change from baseline Perceived Stress Scale at 4 months

    Time frame: 0 to 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.

  22. Change from Baseline Insulin Sensitivity at 4 months

    Time frame: 0 to 4 months

    insulin sensitivity HOMA-β (= 360 x insulin mg/dL / glucose mg/dL - 63; %).

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Egg Nutrition Center

Registry information

Acronym: EGGSPDITe

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 11, 2018
Registry last updated
Sep 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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