A High Protein Weight Loss Intervention for Sarcopenic Obesity in Women (POWR-UP)

Duke University

Status

Completed

Conditions

Weight Loss

Obesity

Treatments

Behavioral: Diet counseling and group education lessons

Dietary Supplement: Protein supplementation

Study type

Interventional

Funder types

Other

Identifiers

NCT02033655

Pro00050540

Details and patient eligibility

About

The purpose of the trial is to 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.

Full description

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.

Enrollment

105 patients

Sex

Female

Ages

45+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

105 participants in 2 patient groups

Weight loss high protein

Experimental group

Description:

Protein supplementation. Subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of protein, including substantial amounts of supplemental protein provided as lean beef. Intakes of \> 30g of high quality protein will be achieved three times a day by subjects in this group, with all or predominantly all from animal source and 60% of animal protein from pork.

Treatment:

Dietary Supplement: Protein supplementation

Behavioral: Diet counseling and group education lessons

Weight loss control

Active Comparator group

Description:

Diet counseling and group education lessons. Subjects follow a calorie-reduction diet for a weight loss of ≥10%.

Treatment:

Behavioral: Diet counseling and group education lessons