An Enhanced Protein (Dairy) Weight Loss Intervention for Dynapenic Obesity: Impact on Muscle Quality and Composition
- Conditions
- ObesityDynapenia
- Interventions
- Behavioral: Weight LossDietary Supplement: Dairy ProteinBehavioral: Low intensity exercise
- Registration Number
- NCT02437643
- Lead Sponsor
- Duke University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 81
- BMI >30;
- SPPB score of ≥4 to <10;
- GFR <45 mL/min
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description WL-LoEX Weight Loss 10% Weight loss diet plus low intensity exercise (protein \~0.8g/kg). Participants will be provided one serving of dairy protein daily. Pro-WL-LoEX Dairy Protein 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. Pro-WL-LoEX Low intensity exercise 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. WL-LoEX Dairy Protein 10% Weight loss diet plus low intensity exercise (protein \~0.8g/kg). Participants will be provided one serving of dairy protein daily. WL-LoEX Low intensity exercise 10% Weight loss diet plus low intensity exercise (protein \~0.8g/kg). Participants will be provided one serving of dairy protein daily. Pro-WL-LoEX Weight Loss 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.
- Primary Outcome Measures
Name Time Method Change in muscle quality 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
Change in muscle adipose infiltration baseline, 3 months, 6 months CT-scan
- Secondary Outcome Measures
Name Time Method Change in Physical Function baseline, 3 months, 6 months short physical performance battery score
Change in Body weight baseline, 3 months, 6 months change in weight
Change in lean Body Mass baseline, 3 months, 6 months DEXA
Change in fat mass baseline, 3 months, 6 months DEXA
Change in 6-minute walk time baseline, 3 months, 6 months 6-minute walk
Change in 8-foot up and go time baseline, 3 months, 6 months time it takes to complete 8-foot up and go
Change in 30 second chair stands baseline, 3 months, 6 months number of chair stands done in 30 seconds
Change in dietary protein intake baseline, 3 months, 6 months 3-day food record
Change in calorie intake baseline, 3 months, 6 months 3-day food record
Change in Bone Mineral Density Baseline and 6-months DEXA
Change in sleep baseline, 3 months, 6 months Pittsburgh sleep quality index
Change in depression baseline, 3 months, 6 months Center for Epidemiologic Studies Depression Scale
Change in hand grip strength baseline, 3 months, 6 months Jamar Hand Dynamometer
Change in physical activity Baseline, 3 months, 6 months Actigraph - accelerometer
Change in quality of life Baseline, 3 months, 6 months SF-36
Trial Locations
- Locations (1)
Duke University Medical Center
🇺🇸Durham, North Carolina, United States