Optimizing Body Composition for Function in Older Adults
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00315146|
Recruitment Status : Completed
First Posted : April 17, 2006
Results First Posted : December 19, 2014
Last Update Posted : March 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Obesity Overweight With Indications for Weight Loss||Drug: Pioglitazone Behavioral: Resistance exercise training to maximize muscle power Behavioral: Hypocaloric diet Drug: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||88 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||Optimizing Body Composition for Function in Older Adults (OPTIMA) - A Pepper Pilot Study|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||April 2007|
|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|
- 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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|