Clinical trial NCT02437643: An Enhanced Protein (Dairy) Weight Loss Intervention for Dynapenic Obesity: Impact on Muscle Quality and Composition
Official title: An Enhanced Protein (Dairy) Weight Loss Intervention for Dynapenic Obesity: Impact on Muscle Quality and Composition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dynapenia
Obesity
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Dairy Research Institute
First posted: 2015-05-07
Enrollment: 81
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in muscle quality
timeFrame: baseline, 3 months, 6 months
measure: Change in muscle adipose infiltration
timeFrame: baseline, 3 months, 6 months
Secondary outcomes:
measure: Change in Physical Function
timeFrame: baseline, 3 months, 6 months
measure: Change in Body weight
timeFrame: baseline, 3 months, 6 months
measure: Change in lean Body Mass
timeFrame: baseline, 3 months, 6 months
measure: Change in lean Body Mass
timeFrame: baseline, 3 months, 6 months
measure: Change in fat mass
timeFrame: baseline, 3 months, 6 months
measure: Change in fat mass
timeFrame: baseline, 3 months, 6 months
measure: Change in 6-minute walk time
timeFrame: baseline, 3 months, 6 months
measure: Change in 8-foot up and go time
timeFrame: baseline, 3 months, 6 months
measure: Change in 30 second chair stands
timeFrame: baseline, 3 months, 6 months
measure: Change in dietary protein intake
timeFrame: baseline, 3 months, 6 months
measure: Change in calorie intake
timeFrame: baseline, 3 months, 6 months
measure: Change in Bone Mineral Density
timeFrame: Baseline and 6-months
measure: Change in sleep
timeFrame: baseline, 3 months, 6 months
measure: Change in depression
timeFrame: baseline, 3 months, 6 months
measure: Change in hand grip strength
timeFrame: baseline, 3 months, 6 months
measure: Change in physical activity
timeFrame: baseline, 3 months, 6 months
measure: Change in physical activity
timeFrame: Baseline, 3 months, 6 months
measure: Change in quality of life
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Connie Bales, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.