A High Protein Weight Loss Intervention for Sarcopenic Obesity in Women

Assess the effects of combining regular, generous intakes of high quality protein (primarily
from lean pork and other animal source proteins) with calorie restriction on functional
status and lean muscle mass in frail, obese, women who participate in a 6 month intervention
and 9 month intervention.

For 6 month intervention: Participants will be randomized into one of two study arms: Weight
Loss Control (n = 20) subjects follow a calorie-reduced diet for a weight loss or ≥10%; or
Weight Loss-High Protein: (n = 40) subjects follow a calorie-reduction diet for a weight loss
of ≥10%, with a high proportion of high quality protein at each meal. Intakes of > 30g of
high quality protein will be achieved three times a day by subjects in this group,
predominantly all from animal sources and 60-70% of animal protein from pork. Subject
criteria will include obese (>30 kg/m2) women (≥ 45 yrs.) with mild to moderate functional
impairment (by 6 minute walk).

For 9 month intervention: Participants will be randomized into one of two study arms: Weight
Loss Control (n = 10) subjects follow a calorie-reduced diet for a weight loss or ≥10%; or
Weight Loss-High Protein: (n = 10) subjects follow a calorie-reduction diet for a weight loss
of ≥10%, with a high proportion of high quality protein at each meal. Intakes of > 30g of
high quality protein will be achieved three times a day by subjects in this group,
predominantly all from animal sources and 60-70% of animal protein from pork. Subject
criteria will include obese (≥ 30 kg/m2) women (≥ 60 yrs.) with mild to moderate functional
impairment (by 6 minute walk).

This is a randomized clinical trial with repeated measurements, with the purpose of assessing
change over time for the overall sample and the difference in the High Protein group relative
to the Control group with regards to primary outcomes (function and lean body mass). The
statistical analyses will proceed chronologically in 3 phases: 1) descriptive analyses that
will summarize the distribution of the covariates and dependent variables, 2) bivariate
analyses of the association between group membership and the outcome measures, and 3)
controlled multivariable analyses, which assess the association between experimental group
and the outcomes, controlling for the important covariates.

Inclusion Criteria:

- Age 45+ yrs.

- BMI of >30 kg/m2

- Body weight <495 lbs.

- Normal blood chemistries

- Normal renal function

- Primary care physician acknowledgement

- Non-Vegetarian

- Mild to moderate movement impairment

Exclusion Criteria:

- Body weight >495 pounds.

- Current smoker.

- Presence of unstable, acutely symptomatic, or life-limiting illness.

- Positive screen for dementia using Mini-Cog evaluation tool.

- Neurological conditions causing functional or cognitive impairments.

- History of significant weight instability (defined as > 10 pounds weight gain or loss
over 6 months prior to study participation).

- Unwillingness or inability to be randomized to any one of two intervention groups,
submit to all study testing or continuously participate in a randomly assigned
lifestyle intervention program for six months.

- Inability to walk independently.

- Bilateral hip replacements.

- Unable to give consent.

- Unable to complete written recording forms including journals of eating and exercise
behaviors.

- Current use of the following medications: monoamine oxidase inhibitors, prescription
weight loss medications.

- Primary Care Physician advises against participation.