Duke University Medical Center
Durham, North Carolina, 27710, United States
NCT Number: NCT02437643
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.
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Notify Me60 year and older
All sexes
Interventional
Not applicable
Durham, North Carolina, 27710, United States
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: baseline, 3 months, 6 months
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
CT-scan
Time frame: baseline, 3 months, 6 months
short physical performance battery score
Time frame: baseline, 3 months, 6 months
change in weight
Time frame: baseline, 3 months, 6 months
BodPod
Time frame: baseline, 3 months, 6 months
DEXA
Time frame: baseline, 3 months, 6 months
BodPod
Time frame: baseline, 3 months, 6 months
DEXA
Time frame: baseline, 3 months, 6 months
6-minute walk
Time frame: baseline, 3 months, 6 months
time it takes to complete 8-foot up and go
Time frame: baseline, 3 months, 6 months
number of chair stands done in 30 seconds
Time frame: baseline, 3 months, 6 months
3-day food record
Time frame: baseline, 3 months, 6 months
3-day food record
Time frame: Baseline and 6-months
DEXA
Time frame: baseline, 3 months, 6 months
Pittsburgh sleep quality index
Time frame: baseline, 3 months, 6 months
Center for Epidemiologic Studies Depression Scale
Time frame: baseline, 3 months, 6 months
Jamar Hand Dynamometer
Time frame: baseline, 3 months, 6 months
Community Health Activities Model Program for Seniors (CHAMPS)
Time frame: Baseline, 3 months, 6 months
Actigraph - accelerometer
Time frame: Baseline, 3 months, 6 months
SF-36
Duke University
Other
Acronym: DDYNAMO
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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