Optimizing Body Composition for Function in Older Adults
|Obesity Overweight With Indications for Weight Loss||Drug: Pioglitazone Behavioral: Resistance exercise training to maximize muscle power Behavioral: Hypocaloric diet Drug: Placebo||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Primary Purpose: Treatment
|Official Title:||Optimizing Body Composition for Function in Older Adults (OPTIMA) - A Pepper Pilot Study|
- Appendicular Non-bone Lean Mass [ Time Frame: Baseline visit (pre intervention) and 4month follow up (post intervention) ]Change in Appendicular Non-bone Lean Mass
- Lean Body Mass [ Time Frame: Baseline visit (pre intervention) and 4month follow up (post intervention) ]
|Study Start Date:||April 2006|
|Study Completion Date:||April 2007|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Hypocaloric diet (and placebo)||Behavioral: Hypocaloric diet Drug: Placebo|
|Active Comparator: Hypocaloric diet, resist. training to maximize power, placebo||Behavioral: Resistance exercise training to maximize muscle power Behavioral: Hypocaloric diet Drug: Placebo|
|Active Comparator: Hypocaloric diet and a PPAR- γ agonist (pioglitazone/Actos™)||Drug: Pioglitazone Behavioral: Hypocaloric diet|
|Active Comparator: Hypocaloric diet,resistance training, pioglitazone/Actos™||Drug: Pioglitazone Behavioral: Resistance exercise training to maximize muscle power Behavioral: Hypocaloric diet|
In this pilot we propose to recruit 88 older (65 - 79 yrs) men (n=48) and women (n=40) at risk for disability and with indications for weight loss according to NIH guidelines. All will be enrolled in a dietary intervention designed to generate a caloric deficit of 500 kcal/day for a 4 month period. All will receive supplemental vitamin D and calcium. These participants will be randomized into one of 4 groups:
Group 1 - Hypocaloric diet (and placebo) Group 2 - Hypocaloric diet and resistance training designed to maximize muscular power (and placebo) Group 3 - Hypocaloric diet and a PPAR- γ agonist (pioglitazone/Actos™) Group 4 - Hypocaloric diet and resistance training and pioglitazone/Actos™
The specific aims of the pilot are:
- In both men and women, to determine whether randomization to resistance exercise is associated with an increased retention of appendicular non-bone lean mass compared to those not undergoing power training.
- In both men and women, to determine whether randomization to the pioglitazone group is associated with an increased loss of visceral adiposity relative to randomization to the non-pioglitazone group.
- Assess the feasibility of the recruitment, assessment and intervention strategies
- To estimate adherence to the weight loss, exercise training, and drug interventions;
- In this population, to determine measurement characteristics of the functional outcomes that will be considered as primary end-points of the larger study.
- To obtain pilot data on a subset of participants to determine the feasibility, acceptability and measurement characteristics of muscle samples (biopsies) to quantify intramyocellular lipid in this study population.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00315146
|United States, North Carolina|
|Sticht Center on Aging, Wake Forest University Baptist Medical Center|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Stephen B Kritchevsky, PhD||Sticht Center on Aging, Wake Forest University School of Medicine|