Measuring Eating, Activity and Strength: Understanding the Response -Using Protein (MEASUR-UP)

December 10, 2018 updated by: Duke University

Does Enhanced Protein Intake Preserve Function and Lean Muscle Mass During Weight Reduction in Frail, Obese Older Adults?

The purpose of the trial is to assess the effects of weight loss on functional status and lean muscle mass in frail, obese older adults (>/= 60) who participate in a 6 month weight reduction intervention. Participants will be randomized into one of two study arms: Weight Loss Control: (n = 25) subjects follow a calorie-reduction diet for a weight loss of ≥10%; or Weight Loss-High Protein: (n = 50) 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 beef. Subject criteria will include obese (>30 kg/m2) older adults (>60 yrs.) with mild to moderate functional impairment (by Short Physical Performance Battery; SPPB score >/= 4)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 60+ 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Individual and group diet counseling to achieve a >10% weight loss
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 60-70% of animal protein from beef.
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 beef.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Short Physical Performance Battery (SPPB)
Time Frame: Baseline to 3 to 6 months
short physical performance battery
Baseline to 3 to 6 months
Change in lean body mass
Time Frame: Baseline to 3 and 6 months
Bodpod
Baseline to 3 and 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 6 months
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).
Baseline to 6 months
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.
Baseline to 6 months
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
Baseline to 6 months
Change in baseline lipids (classes, subclasses, participle size and number) at 6 months
Time Frame: Baseline to 6 months
Concentrations for lipoprotein classes (VLDL, LDL and HDL particle numbers) and subclasses (small, medium and large) were calculated using the LP3 deconvolution algorithm. 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
Time Frame: Baseline to 6 months
NMR-measured systemic inflammatory factor and a biomarker of CVD risk
Baseline to 6 months
Change in baseline branched chain amino acids (BCAA) at 6 months
Time Frame: Baseline to 6 months
NMR MetaboProfile analysis, which reports concentrations of several metabolites [ the branched chain amino acids (BCAA) valine, leucine, and isoleucine] was performed using the recently developed LP3 deconvolution algorithm.
Baseline to 6 months
Change in baseline 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.
Baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Connie W Bales, PhD, RD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

October 25, 2012

First Submitted That Met QC Criteria

October 26, 2012

First Posted (Estimate)

October 29, 2012

Study Record Updates

Last Update Posted (Actual)

December 12, 2018

Last Update Submitted That Met QC Criteria

December 10, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00037110
  • 3834193 (Other Grant/Funding Number: National Cattlemen's Beef Association)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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