An Enhanced Protein (Dairy) Weight Loss Intervention for Dynapenic Obesity: Impact on Muscle Quality and Composition

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Weight loss plus low-intensity exercise intervention (WL-LoEX; n = 35): Subjects follow a calorie-reduction diet for a weight loss of ≥10%, protein 0.8g/g/d. Subjects will also participate in three 30-minute low-intensity exercise sessions weekly. One serving of dairy protein/day will be provided to WL-LoEX participants. High protein weight loss plus low-intensity exercise intervention (PRO-WL-LoEX; n = 35): 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 dairy foods that will be provided. Subjects will also participate in three 30-minute low-intensity exercise sessions weekly.

Official Title
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An Enhanced Protein (Dairy) Weight Loss Intervention for Dynapenic Obesity: Impact on Muscle Quality and Composition

Conditions
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Dynapenia, Obesity

Intervention / Treatment
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* Behavioral: Weight Loss
* Dietary Supplement: Dairy Protein
* Behavioral: Low intensity exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI >30; SPPB score of ≥4 to <10; GFR <45 mL/min Exclusion Criteria: Body weight >495 lbs. (BodPod limits); estimated glomerular filtration rates (eGFR) less than 45 mL/min; symptomatic cardiac disease; receiving chemotherapy; hemophilia; presence of unstable or symptomatic life-threatening illness; neurological disease or disorder causing functional impairments; inability to walk, dementia; prescription weight loss medications; use of monamine oxidase inhibitors (MAOIs); or primary medical provider advises against participation.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: WL-LoEX<br>10% Weight loss diet plus low intensity exercise (protein  0.8g/kg). Participants will be provided one serving of dairy protein daily. | Behavioral: Weight Loss<br>* Participants will be prescribed hypo-caloric diet prescription.<br>Dietary Supplement: Dairy Protein<br>* 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.<br>Behavioral: Low intensity exercise<br>* Participants in both groups will participate in chair exercises 3 times a week.<br>|
| Active Comparator: Pro-WL-LoEX<br>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. | Behavioral: Weight Loss<br>* Participants will be prescribed hypo-caloric diet prescription.<br>Dietary Supplement: Dairy Protein<br>* 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.<br>Behavioral: Low intensity exercise<br>* Participants in both groups will participate in chair exercises 3 times a week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |