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: * 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
81
Participants will be prescribed hypo-caloric diet prescription.
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.
Participants in both groups will participate in chair exercises 3 times a week.
Duke University Medical Center
Durham, North Carolina, United States
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
Time frame: baseline, 3 months, 6 months
Change in muscle adipose infiltration
CT-scan
Time frame: baseline, 3 months, 6 months
Change in Physical Function
short physical performance battery score
Time frame: baseline, 3 months, 6 months
Change in Body weight
change in weight
Time frame: baseline, 3 months, 6 months
Change in lean Body Mass
BodPod
Time frame: baseline, 3 months, 6 months
Change in lean Body Mass
DEXA
Time frame: baseline, 3 months, 6 months
Change in fat mass
BodPod
Time frame: baseline, 3 months, 6 months
Change in fat mass
DEXA
Time frame: baseline, 3 months, 6 months
Change in 6-minute walk time
6-minute walk
Time frame: baseline, 3 months, 6 months
Change in 8-foot up and go time
time it takes to complete 8-foot up and go
Time frame: baseline, 3 months, 6 months
Change in 30 second chair stands
number of chair stands done in 30 seconds
Time frame: baseline, 3 months, 6 months
Change in dietary protein intake
3-day food record
Time frame: baseline, 3 months, 6 months
Change in calorie intake
3-day food record
Time frame: baseline, 3 months, 6 months
Change in Bone Mineral Density
DEXA
Time frame: Baseline and 6-months
Change in sleep
Pittsburgh sleep quality index
Time frame: baseline, 3 months, 6 months
Change in depression
Center for Epidemiologic Studies Depression Scale
Time frame: baseline, 3 months, 6 months
Change in hand grip strength
Jamar Hand Dynamometer
Time frame: baseline, 3 months, 6 months
Change in physical activity
Community Health Activities Model Program for Seniors (CHAMPS)
Time frame: baseline, 3 months, 6 months
Change in physical activity
Actigraph - accelerometer
Time frame: Baseline, 3 months, 6 months
Change in quality of life
SF-36
Time frame: Baseline, 3 months, 6 months
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