Optimizing Body Composition for Function in Older Adults

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight With Indications for Weight Loss
• Intervention / Treatment: Drug: Placebo; Behavioral: Hypocaloric diet; Drug: Pioglitazone; Behavioral: Resistance exercise training to maximize muscle power

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Sticht Center on Aging, Wake Forest University Baptist Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 79 years (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Hypocaloric diet (and placebo)	Drug: Placebo; Behavioral: Hypocaloric diet
Active Comparator: Hypocaloric diet, resist. training to maximize power, placebo	Drug: Placebo; Behavioral: Hypocaloric diet; Behavioral: Resistance exercise training to maximize muscle power
Active Comparator: Hypocaloric diet and a PPAR- γ agonist (pioglitazone/Actos™)	Behavioral: Hypocaloric diet; Drug: Pioglitazone
Active Comparator: Hypocaloric diet,resistance training, pioglitazone/Actos™	Behavioral: Hypocaloric diet; Drug: Pioglitazone; Behavioral: Resistance exercise training to maximize muscle power

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appendicular Non-bone Lean Mass	Change in Appendicular Non-bone Lean Mass	Baseline visit (pre intervention) and 4month follow up (post intervention)

Secondary Outcome Measures

Outcome Measure	Time Frame
Lean Body Mass	Baseline visit (pre intervention) and 4month follow up (post intervention)

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Institute on Aging (NIA); Takeda Pharmaceuticals North America, Inc.
• Investigators: Principal Investigator: Stephen B Kritchevsky, PhD, Sticht Center on Aging, Wake Forest University School of Medicine

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): April 1, 2007
• Study Completion (Actual): April 1, 2007

Study Registration Dates

• First Submitted: April 13, 2006
• First Submitted That Met QC Criteria: April 13, 2006
• First Posted (Estimate): April 17, 2006

Study Record Updates

• Last Update Posted (Actual): August 28, 2018
• Last Update Submitted That Met QC Criteria: July 30, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Elderly; Body Composition; Sarcopenia; Intervention studies; Weight loss trials
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss; Overweight; Hypoglycemic Agents; Physiological Effects of Drugs; Pioglitazone
• Other Study ID Numbers: BG06-051; P30AG021332 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No