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Completed

NCT Number: NCT01715753

Measuring Eating, Activity and Strength: Understanding the Response -Using Protein

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)

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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Protein supplementation

Dietary Supplement

> 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.

Diet counseling and group education lessons

Behavioral

Individual and group diet counseling to achieve a >10% weight loss

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Acronym: MEASUR-UP

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 29, 2012
Registry last updated
Dec 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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