Clinical trial NCT03771261: Balanced (Egg) Protein During Obesity Reduction: Differential Responses of Insulin Resistance by Race
Official title: Balanced (Egg) Protein During Obesity Reduction: Differential Responses of Insulin Resistance by Race
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre Diabetes
Obesity
Keywords: Egg
Protein
Aging
Health Disparities
Weight Loss
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Egg Nutrition Center
First posted: 2018-12-11
Enrollment: 99
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from Baseline Insulin Resistance at 4 months
timeFrame: 0 to 4 months
measure: Change from Baseline Body weight at 4 months
timeFrame: 0 to 4 months
Secondary outcomes:
measure: Change from baseline Short Physical Performance Battery at 4 months
timeFrame: 0 to 4 months
measure: Change from baseline 6-minute walk (meters) at 4 months
timeFrame: 0 to 4 months
measure: Change from baseline 8-foot up and Go time at 4 months
timeFrame: 0 to 4 months
measure: Change from baseline 30-second chair stands (number of stands) at 4 months
timeFrame: 0 to 4 months
measure: Change from baseline handgrip strength at 4 months
timeFrame: 0 to 4 months
measure: Change from baseline grooved pegboard time at 4 months
timeFrame: 0 to 4 months
measure: Change from baseline fat mass (%) at 4 months
timeFrame: 0 to 4 months
measure: Change from baseline fat mass (kgs) at 4 months
timeFrame: 0 to 4 months
measure: Change from baseline lean mass (kgs) at 4 months
timeFrame: 0 to 4 months
measure: Change from baseline lean mass (%) at 4 months
timeFrame: 0 to 4 months
measure: Change from baseline minimal waist circumference at 4 months
timeFrame: 0 to 4 months
measure: Change from baseline umbilical waist circumference at 4 months
timeFrame: 0 to 4 months
measure: Change from baseline hip circumference at 4 months
timeFrame: 0 to 4 months
measure: Change from baseline total calories at 4 months
timeFrame: 0 to 4 months
measure: Change from baseline macronutrient intake at 4 months
timeFrame: 0 to 4 months
measure: Change from baseline micronutrient intake at 4 months
timeFrame: 0 to 4 months
measure: Change from baseline Symbol digit modalities test at 4 months
timeFrame: 0 to 4 months
measure: Change from baseline Trail Making Test at 4 months
timeFrame: 0 to 4 months
measure: Change from baseline Hopkins Verbal Learning Test at 4 months
timeFrame: 0 to 4 months
measure: Change from baseline Profile of Mood States at 4 months
timeFrame: 0 to 4 months
measure: Change from baseline Perceived Stress Scale at 4 months
timeFrame: 0 to 4 months
measure: Change from Baseline Insulin Sensitivity at 4 months
timeFrame: 0 to 4 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Connie Bales, RD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.