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| Name | Class |
|---|---|
| Egg Nutrition Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight Loss | Behavioral | Participants will be prescribed hypo-caloric diet by a registered dietitian and attend weekly social support/nutrition education meetings. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Short Physical Performance Battery at 4 months | Physical Performance as measured by Short Physical Performance Battery (SPPB) | 0 to 4 months |
| Change from baseline 6-minute walk (meters) at 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Connie Bales, RD, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24445063 | Background | 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. | |
| 26786203 | Background | 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. |
| Label | URL |
|---|---|
| Duke University School of Medicine | View source |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004527 | Egg Proteins |
| ID | Term |
|---|---|
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Egg Protein | Dietary Supplement | Participants will be provided pre-packaged hard-boiled eggs (3/day, medium) and egg white protein powder. |
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Distance (meters) walked in 6 minutes
| 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) | 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 | 0 to 4 months |
| Change from baseline handgrip strength at 4 months | the highest weight achieved from 2 attempts using the JAMAR dynamometer | 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 | 0 to 4 months |
| Change from baseline fat mass (%) at 4 months | Body fat mass (%) as measured by Bodpod | 0 to 4 months |
| Change from baseline fat mass (kgs) at 4 months | Body fat mass (kg) as measured by Bodpod | 0 to 4 months |
| Change from baseline lean mass (kgs) at 4 months | Body lean mass (kg) as measured by Bodpod | 0 to 4 months |
| Change from baseline lean mass (%) at 4 months | Body lean mass (%) as measured by Bodpod | 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. | 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. | 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. | 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) | 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) | 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) | 0 to 4 months |
| Change from baseline Symbol digit modalities test at 4 months | Symbol Digit Modalities Test measures cognitive impairment | 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. | 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. | 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". | 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. | 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; %). | 0 to 4 months |
| 27153084 | Background | 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. |
| Egg Nutrition Center | View source |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |