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

Duke University99 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pre Diabetes

Interventions

Weight LossBEHAVIORAL

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

Egg ProteinDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

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)

Time frame: 0 to 4 months

Change from Baseline Body weight at 4 months

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

Time frame: 0 to 4 months

Secondary Outcomes

Change from baseline Short Physical Performance Battery at 4 months

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

Time frame: 0 to 4 months

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

Distance (meters) walked in 6 minutes

Time frame: 0 to 4 months

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)

Time frame: 0 to 4 months

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

the number of chair stands completed in 30 seconds

Time frame: 0 to 4 months

Change from baseline handgrip strength at 4 months

the highest weight achieved from 2 attempts using the JAMAR dynamometer

Time frame: 0 to 4 months

Change from baseline grooved pegboard time at 4 months

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

Time frame: 0 to 4 months

Change from baseline fat mass (%) at 4 months

Body fat mass (%) as measured by Bodpod

Time frame: 0 to 4 months

Change from baseline fat mass (kgs) at 4 months

Body fat mass (kg) as measured by Bodpod

Time frame: 0 to 4 months

Change from baseline lean mass (kgs) at 4 months

Body lean mass (kg) as measured by Bodpod

Time frame: 0 to 4 months

Change from baseline lean mass (%) at 4 months

Body lean mass (%) as measured by Bodpod

Time frame: 0 to 4 months

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.

Time frame: 0 to 4 months

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.

Time frame: 0 to 4 months

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.

Time frame: 0 to 4 months

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)

Time frame: 0 to 4 months

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)

Time frame: 0 to 4 months

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)

Time frame: 0 to 4 months

Change from baseline Symbol digit modalities test at 4 months

Symbol Digit Modalities Test measures cognitive impairment

Time frame: 0 to 4 months

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.

Time frame: 0 to 4 months

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.

Time frame: 0 to 4 months

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".

Time frame: 0 to 4 months

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.

Time frame: 0 to 4 months

Change from Baseline Insulin Sensitivity at 4 months

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

Time frame: 0 to 4 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.