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

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ClinicalTrials.gov Identifier: NCT01715753
Recruitment Status : Completed
First Posted : October 29, 2012
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
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 or disease Intervention/treatment Phase
Weight Loss Dietary Supplement: Protein supplementation Behavioral: Diet counseling and group education lessons Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Does Enhanced Protein Intake Preserve Function and Lean Muscle Mass During Weight Reduction in Frail, Obese Older Adults?
Study Start Date : September 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in Short Physical Performance Battery (SPPB) [ Time Frame: Baseline to 3 to 6 months ]
    short physical performance battery

  2. Change in lean body mass [ Time Frame: Baseline to 3 and 6 months ]
    Bodpod


Other Outcome Measures:
  1. 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.

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

  3. 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.

  4. 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).

  5. 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.

  6. 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.

  7. 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.

  8. 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



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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): NCT01715753


Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Connie W Bales, PhD, RD Duke University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01715753     History of Changes
Other Study ID Numbers: Pro00037110
3834193 ( Other Grant/Funding Number: National Cattlemen's Beef Association )
First Posted: October 29, 2012    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: March 2018

Keywords provided by Duke University:
Function
Muscle mass

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