Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02033655
Recruitment Status : Completed
First Posted : January 13, 2014
Last Update Posted : January 8, 2019
Sponsor:
Collaborator:
National Pork Board
Information provided by (Responsible Party):
Duke University

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 Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : March 2014
Actual Primary Completion Date : August 22, 2018
Actual Study Completion Date : August 22, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Physical function [ Time Frame: Baseline, 4, 6, and 9 months ]
    Assess the change in 6 minute walk scores at 4, 6, and 9 months

  2. Lean Mass [ Time Frame: Baseline, 4, 6, and 9 months ]
    To assess the change in lean mass at 3 or 4 time points.


Secondary Outcome Measures :
  1. Physical Function [ Time Frame: Baseline, 4, 6, and 9 months ]
    To assess the change in SPPB at 4, 6, and 9 months

  2. Weight Loss [ Time Frame: Baseline, 4, 6, and 9 months ]
    To assess the change in body weight at 4, 6, and 9 months

  3. Fat Mass [ Time Frame: Baseline, 4, 6, and 9 months ]
    To assess the change in fat mass at 4, 6, and 9 months


Other Outcome Measures:
  1. Change in baseline lipid classes at 6 months [ Time Frame: Baseline to 6 months ]
    Concentrations for lipoprotein classes (VLDL, LDL and HDL particle numbers) were calculated using the LP3 deconvolution algorithm.

  2. Change in baseline lipid subclasses at 6 months [ Time Frame: Baseline to 6 months ]
    Concentrations for lipoprotein (VLDL, LDL, and HDL) subclasses (small, medium and large) were calculated using the LP3 deconvolution algorithm.

  3. Change in baseline lipid participle sizes at 6 months [ Time Frame: 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.

  4. Changes in baseline GlycA at 6 months [ Time Frame: Baseline to 6 months ]
    NMR-measured systemic inflammatory factor and a biomarker of CVD risk.

  5. Change in baseline trimethylamine-N-oxide (TMAO) at 6 months [ Time Frame: 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.

  6. Change in baseline betaine at 6 months [ Time Frame: Baseline to 6 months ]
    Betaine was measured by 1H-nuclear magnetic resonance (NMR) spectroscopy using a Vantera® NMR Clinical Analyzer (LabCorp, Raleigh, NC).

  7. Change in baseline Lipoprotein Insulin Resistance Index (LP-IR) scores at 6 months [ Time Frame: 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.

  8. Change in baseline Estimated GFR at 6 months [ Time Frame: 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.

  9. Change in baseline fasting glucose at 6 months [ Time Frame: Baseline to 6 months ]
    Level of glucose in the blood after fasting for at least 8 hours



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033655


Locations
Layout table for location information
United States, North Carolina
Duke Universtiy Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Pork Board
Investigators
Layout table for investigator information
Principal Investigator: Connie W Bales, PhD, RD Duke University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02033655     History of Changes
Other Study ID Numbers: Pro00050540
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: September 2018
Keywords provided by Duke University:
weight loss
older adults
obesity
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Body Weight
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Signs and Symptoms
Body Weight Changes