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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Weight Loss
• Intervention / Treatment: Dietary supplement: Protein supplementation; Behavioral: Diet counseling and group education lessons

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 Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Universtiy Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Function	To assess the change in SPPB at 4, 6, and 9 months	Baseline, 4, 6, and 9 months
Weight Loss	To assess the change in body weight at 4, 6, and 9 months	Baseline, 4, 6, and 9 months
Fat Mass	To assess the change in fat mass at 4, 6, and 9 months	Baseline, 4, 6, and 9 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in baseline lipid classes at 6 months	Concentrations for lipoprotein classes (VLDL, LDL and HDL particle numbers) were calculated using the LP3 deconvolution algorithm.	Baseline to 6 months
Change in baseline lipid subclasses at 6 months	Concentrations for lipoprotein (VLDL, LDL, and HDL) subclasses (small, medium and large) were calculated using the LP3 deconvolution algorithm.	Baseline to 6 months
Change in baseline lipid participle sizes at 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.	Baseline to 6 months
Changes in baseline GlycA at 6 months	NMR-measured systemic inflammatory factor and a biomarker of CVD risk.	Baseline to 6 months
Change in baseline trimethylamine-N-oxide (TMAO) at 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.	Baseline to 6 months
Change in baseline betaine at 6 months	Betaine was measured by 1H-nuclear magnetic resonance (NMR) spectroscopy using a Vantera® NMR Clinical Analyzer (LabCorp, Raleigh, NC).	Baseline to 6 months
Change in baseline Lipoprotein Insulin Resistance Index (LP-IR) scores at 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.	Baseline to 6 months
Change in baseline Estimated GFR at 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.	Baseline to 6 months
Change in baseline fasting glucose at 6 months	Level of glucose in the blood after fasting for at least 8 hours	Baseline to 6 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Pork Board
• Investigators: Principal Investigator: Connie W Bales, PhD, RD, Duke University

Publications and helpful links

General Publications

• Bales CW, Porter Starr KN, Orenduff MC, McDonald SR, Molnar K, Jarman AK, Onyenwoke A, Mulder H, Payne ME, Pieper CF. Influence of Protein Intake, Race, and Age on Responses to a Weight-Reduction Intervention in Obese Women. Curr Dev Nutr. 2017 May 1;1(5):e000703. doi: 10.3945/cdn.117.000703. Epub 2017 Apr 11.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): August 22, 2018
• Study Completion (Actual): August 22, 2018

Study Registration Dates

• First Submitted: January 9, 2014
• First Submitted That Met QC Criteria: January 9, 2014
• First Posted (Estimate): January 13, 2014

Study Record Updates

• Last Update Posted (Actual): January 8, 2019
• Last Update Submitted That Met QC Criteria: January 4, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: older adults; obesity; weight loss
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight Changes; Obesity; Weight Loss; Body Weight
• Other Study ID Numbers: Pro00050540