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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01715753
First received: October 25, 2012
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

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)


Condition Intervention
Weight Loss
Dietary Supplement: Protein supplementation
Behavioral: Diet counseling and group education lessons

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Does Enhanced Protein Intake Preserve Function and Lean Muscle Mass During Weight Reduction in Frail, Obese Older Adults?

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Change in Short Physical Performance Battery (SPPB) [ Time Frame: Baseline to 3 to 6 months ] [ Designated as safety issue: No ]
  • Change in lean body mass [ Time Frame: Baseline to 3 and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01715753

Contacts
Contact: Melissa Orenduff, BS 919-660-7507 melissa.orenduff@duke.edu
Contact: Kathryn Starr, PhD 919-660-7571 kathryn.starr@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Melissa Orenduff, BS    919-660-7507    melissa.orenduff@duke.edu   
Contact: Kathryn Starr, PhD       kathryn.starr@duke.edu   
Principal Investigator: Connie Bales, PhD         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Connie W Bales, PhD, RD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01715753     History of Changes
Other Study ID Numbers: Pro00037110, 3834193
Study First Received: October 25, 2012
Last Updated: July 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Function
Muscle mass

Additional relevant MeSH terms:
Weight Loss
Body Weight
Body Weight Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014