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

Sponsor

Duke University (Other)

Overall Status

Completed

CT.gov ID

NCT02033655

Collaborator

National Pork Board (Other)

105

Enrollment

Location

Arms

53.7

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Weight Loss Obesity	Dietary Supplement: Protein supplementation Behavioral: Diet counseling and group education lessons	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

105 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A High Protein Weight Loss Intervention for Sarcopenic Obesity in Women

Study Start Date :

Mar 1, 2014

Actual Primary Completion Date :

Aug 22, 2018

Actual Study Completion Date :

Aug 22, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Weight loss high protein 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.	Dietary Supplement: Protein supplementation > 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 60-70% of animal protein from lean pork. Behavioral: Diet counseling and group education lessons Participants meet once a week for 6 months to participate in group lessons and counseling.
Active Comparator: Weight loss control Diet counseling and group education lessons. Subjects follow a calorie-reduction diet for a weight loss of ≥10%.	Behavioral: Diet counseling and group education lessons Participants meet once a week for 6 months to participate in group lessons and counseling.

Arm

Intervention/Treatment

Experimental: Weight loss high protein

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.

Dietary Supplement: Protein supplementation

> 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 60-70% of animal protein from lean pork.

Behavioral: Diet counseling and group education lessons

Participants meet once a week for 6 months to participate in group lessons and counseling.

Active Comparator: Weight loss control

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

Behavioral: Diet counseling and group education lessons

Participants meet once a week for 6 months to participate in group lessons and counseling.

Outcome Measures

Primary Outcome Measures

Physical function [Baseline, 4, 6, and 9 months]
Assess the change in 6 minute walk scores at 4, 6, and 9 months
Lean Mass [Baseline, 4, 6, and 9 months]
To assess the change in lean mass at 3 or 4 time points.

Secondary Outcome Measures

Physical Function [Baseline, 4, 6, and 9 months]
To assess the change in SPPB at 4, 6, and 9 months
Weight Loss [Baseline, 4, 6, and 9 months]
To assess the change in body weight at 4, 6, and 9 months
Fat Mass [Baseline, 4, 6, and 9 months]
To assess the change in fat mass at 4, 6, and 9 months

Other Outcome Measures

Change in baseline lipid classes at 6 months [Baseline to 6 months]
Concentrations for lipoprotein classes (VLDL, LDL and HDL particle numbers) were calculated using the LP3 deconvolution algorithm.
Change in baseline lipid subclasses at 6 months [Baseline to 6 months]
Concentrations for lipoprotein (VLDL, LDL, and HDL) subclasses (small, medium and large) were calculated using the LP3 deconvolution algorithm.
Change in baseline lipid participle sizes at 6 months [Baseline to 6 months]
Mean VLDL, LDL and HDL particle sizes were weighted averages derived from the sum of the diameter of each subclass multiplied by its relative mass percentage.
Changes in baseline GlycA at 6 months [Baseline to 6 months]
NMR-measured systemic inflammatory factor and a biomarker of CVD risk.
Change in baseline trimethylamine-N-oxide (TMAO) at 6 months [Baseline to 6 months]
TMAO is a metabolite produced from trimethylamine (TMA) containing nutrients. Nuclear magnetic resonance (NMR) spectroscopy assay was used for quantification of TMAO concentrations.
Change in baseline betaine at 6 months [Baseline to 6 months]
Betaine was measured by 1H-nuclear magnetic resonance (NMR) spectroscopy using a Vantera® NMR Clinical Analyzer (LabCorp, Raleigh, NC).
Change in baseline Lipoprotein Insulin Resistance Index (LP-IR) scores at 6 months [Baseline to 6 months]
LP-IR is a composite metabolomic biomarker that captures the multidimensional effects of insulin resistance on the lipoprotein metabolic chain. It is measured by nuclear magnetic resonance spectroscopy as a weighted score of VLDL, LDL and HDL particle sizes, and their subsets concentrations.
Change in baseline Estimated GFR at 6 months [Baseline to 6 months]
Estimated GFR, which measures renal filtering capacity, is a calculated value based on age, sex, race, and serum creatinine using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
Change in baseline fasting glucose at 6 months [Baseline to 6 months]
Level of glucose in the blood after fasting for at least 8 hours

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

Female

Accepts 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.