Optimizing Body Composition in Older Adults (OPTIMA)

Long Name:Optimizing Body Composition in Older Adults (OPTIMA)

In this pilot recruited 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 were enrolled in a dietary intervention designed to generate a caloric deficit of 500 kcal/day for a 4 month period.  All will received supplemental vitamin D and calcium.  These participants were 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.

The primary body composition assessments will use a DEXA and CT scan to quantify follow-up group differences in:

  1. Appendicular non-bone lean mass;  and
  2. Abdominal visceral fat area

Secondary body composition outcomes include:

  1. Waist circumference
  2.  In a subset of participants (8 per group) muscle samples (biopsies) were obtained to document changes in intramyocellular lipid accumulation.

Secondary metabolic/functional outcomes include:

Metabolic/Disease Risk Factors:

            a. Blood pressure

            b. Fasting glucose

            c. LDL cholesterol, HDL cholesterol, triglycerides

Items a.-c. are measured as part of the screening criteria, and will be measured again at the end of the study period as well to provide these data to the participants.

Functional Measures:

            a. Pepper Disability Questionnaire

            b. EPESE Short Physical Performance Battery (SPPB)

            c. Grip Strength

            d. Isometric Knee Extensor Strength

            e. 400 M Walk (at usual pace)

            f. Leg Press Power

            g. Depressive symptoms (CES-D)

 

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