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| Name | Class |
|---|---|
| Dairy Research Institute | OTHER |
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The purpose of the trial is to assess the effects of combining regular, generous intakes of high quality protein (primarily from dairy and other animal source proteins) with calorie restriction and low-intensity exercise on muscle quality and muscle adipose infiltration (along with bone mineral density [BMD] and a number of secondary outcomes) in frail, obese, older adults participating in a 6 month intervention. The investigators will compare these effects to those of a traditional control regimen of calorie restriction and low-intensity exercise over the same duration.
Obese older adults (≥60 yrs) with moderate functional impairment will be randomized to 1 of 2 study arms. Outcomes to be measured at 0, 3 and 6 months are as follows: Primary outcomes- (1) Muscle Quality (MQ): muscle power (time to perform ten chair rises, height of the chair, leg length, body mass, and acceleration of gravity) in relation to muscle mass (CT-scan) and (2) Muscle adipose infiltration (MAI) (CT-scan). Secondary outcomes- Bone Mineral Density (BMD; DXA scan) physical function (Short Physical Performance Battery (SPPB); 6 minute walk; 8-foot up and go; and 30 second chair stands; handgrip strength; body weight; fat mass; waist circumference; activity (accelerometers); mental health (sleep, depression, quality of life); and feasibility factors (adherence, protein intake, nutrition adequacy). BMD will only be accessed at 0 and 6 months.
Study Arms:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WL-LoEX | Placebo Comparator | 10% Weight loss diet plus low intensity exercise (protein ~0.8g/kg). Participants will be provided one serving of dairy protein daily. |
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| Pro-WL-LoEX | Active Comparator | Protein-enhanced 10% Weight loss diet plus low intensity exercise (protein ~1.2 g/kg with > 30g per meal and >60% as dairy). Participants will be provided at least 8 servings of dairy protein daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight Loss | Behavioral | Participants will be prescribed hypo-caloric diet prescription. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in muscle quality | composite score of time to perform ten chair rises, height of the chair, leg length, body mass, and acceleration of gravity in relation to muscle mass | baseline, 3 months, 6 months |
| Change in muscle adipose infiltration | CT-scan | baseline, 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Physical Function | short physical performance battery score | baseline, 3 months, 6 months |
| Change in Body weight | change in weight |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Connie Bales, PhD, RD | 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 |
|---|---|---|---|
| 33719918 | Derived | Miller MG, Porter Starr KN, Rincker J, Orenduff MC, McDonald SR, Pieper CF, Fruik AR, Lyles KW, Bales CW. Rationale and Design for a Higher (Dairy) Protein Weight Loss Intervention That Promotes Muscle Quality and Bone Health in Older Adults with Obesity: A Randomized, Controlled Pilot Study. J Nutr Gerontol Geriatr. 2021 Apr-Jun;40(2-3):150-170. doi: 10.1080/21551197.2021.1896615. Epub 2021 Mar 13. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Dairy Protein | Dietary Supplement | Participants will be provided dairy products: WL-LoEx will be provided 1 dairy serving per day and Pro-WL-LoEx will be provided 8 dairy servings per day. |
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| Low intensity exercise | Behavioral | Participants in both groups will participate in chair exercises 3 times a week. |
|
| baseline, 3 months, 6 months |
| Change in lean Body Mass | BodPod | baseline, 3 months, 6 months |
| Change in lean Body Mass | DEXA | baseline, 3 months, 6 months |
| Change in fat mass | BodPod | baseline, 3 months, 6 months |
| Change in fat mass | DEXA | baseline, 3 months, 6 months |
| Change in 6-minute walk time | 6-minute walk | baseline, 3 months, 6 months |
| Change in 8-foot up and go time | time it takes to complete 8-foot up and go | baseline, 3 months, 6 months |
| Change in 30 second chair stands | number of chair stands done in 30 seconds | baseline, 3 months, 6 months |
| Change in dietary protein intake | 3-day food record | baseline, 3 months, 6 months |
| Change in calorie intake | 3-day food record | baseline, 3 months, 6 months |
| Change in Bone Mineral Density | DEXA | Baseline and 6-months |
| Change in sleep | Pittsburgh sleep quality index | baseline, 3 months, 6 months |
| Change in depression | Center for Epidemiologic Studies Depression Scale | baseline, 3 months, 6 months |
| Change in hand grip strength | Jamar Hand Dynamometer | baseline, 3 months, 6 months |
| Change in physical activity | Community Health Activities Model Program for Seniors (CHAMPS) | baseline, 3 months, 6 months |
| Change in physical activity | Actigraph - accelerometer | Baseline, 3 months, 6 months |
| Change in quality of life | SF-36 | Baseline, 3 months, 6 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |