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Optimizing Body Composition for Function in Older Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00315146
First Posted: April 17, 2006
Last Update Posted: March 7, 2017
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.
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Stephen Kritchevsky, Ph.D., Wake Forest University Health Sciences
  Purpose
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.

Condition Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Optimizing Body Composition for Function in Older Adults (OPTIMA) - A Pepper Pilot Study

Further study details as provided by Stephen Kritchevsky, Ph.D., Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Appendicular Non-bone Lean Mass [ Time Frame: Baseline visit (pre intervention) and 4month follow up (post intervention) ]
    Change in Appendicular Non-bone Lean Mass


Secondary Outcome Measures:
  • Lean Body Mass [ Time Frame: Baseline visit (pre intervention) and 4month follow up (post intervention) ]

Enrollment: 88
Study Start Date: April 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, North Carolina
Sticht Center on Aging, Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Takeda Pharmaceuticals North America, Inc.
Investigators
Principal Investigator: Stephen B Kritchevsky, PhD Sticht Center on Aging, Wake Forest University School of Medicine
  More Information

Responsible Party: Stephen Kritchevsky, Ph.D., Professor, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00315146     History of Changes
Other Study ID Numbers: P30-AG021332-2006
First Submitted: April 13, 2006
First Posted: April 17, 2006
Results First Submitted: March 7, 2013
Results First Posted: December 19, 2014
Last Update Posted: March 7, 2017
Last Verified: January 2017

Keywords provided by Stephen Kritchevsky, Ph.D., Wake Forest University Health Sciences:
Body Composition
Sarcopenia
Weight loss trials
Intervention studies
Elderly

Additional relevant MeSH terms:
Overweight
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs