Optimizing Body Composition for Function in Older Adults
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 65 - 79 |
| Updated: | 8/30/2018 |
| Start Date: | April 2006 |
| End Date: | April 2007 |
Optimizing Body Composition for Function in Older Adults (OPTIMA) - A Pepper Pilot Study
The purpose of this pilot study is to compare two strategies intended to improve the health
of overweight older adults by improving body composition. One strategy, resistance training,
is designed to preserve skeletal muscle mass. The other strategy, the use of a PPAR-γ
agonist, is designed to enhance the loss of fat from visceral and skeletal depots. These
strategies will be used in conjunction with a hypocaloric diet and will be compared to a
hypocaloric diet alone to determine if either of these strategies are superior in reducing
visceral fat and preserving muscle mass.
of overweight older adults by improving body composition. One strategy, resistance training,
is designed to preserve skeletal muscle mass. The other strategy, the use of a PPAR-γ
agonist, is designed to enhance the loss of fat from visceral and skeletal depots. These
strategies will be used in conjunction with a hypocaloric diet and will be compared to a
hypocaloric diet alone to determine if either of these strategies are superior in reducing
visceral fat and preserving muscle mass.
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:
1. 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.
2. 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.
3. Assess the feasibility of the recruitment, assessment and intervention strategies
4. To estimate adherence to the weight loss, exercise training, and drug interventions;
5. In this population, to determine measurement characteristics of the functional outcomes
that will be considered as primary end-points of the larger study.
6. 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.
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:
1. 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.
2. 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.
3. Assess the feasibility of the recruitment, assessment and intervention strategies
4. To estimate adherence to the weight loss, exercise training, and drug interventions;
5. In this population, to determine measurement characteristics of the functional outcomes
that will be considered as primary end-points of the larger study.
6. 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.
Inclusion Criteria:
- Weight Stable, Indication for weight loss per NIH guidelines, Performance on the short
physical performance battery score 3-10
Exclusion Criteria:
- Diabetes, weight > 136 kg, Medical condition that limits exercise participation,
Congestive heart failure, abnormal kidney function, higher ALT than normal, currently
involved in a weight loss or exercise program, current smoking, alcohol or drug abuse,
taking anti-inflammatory steroids, taking protein supplements, taking PPAR-gamma
agonist, edema, anemia
We found this trial at
1
site
Winston-Salem, North Carolina 27157
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