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

Primary Purpose

Weight Loss

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Protein supplementation

Diet counseling and group education lessons

About this trial

This is an interventional prevention trial for Weight Loss focused on measuring Function, Muscle mass

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Weight Loss Control

Weight Loss-High Protein

Arm Description

Diet counseling and group education lessons. Subjects follow a calorie-reduction diet for a weight loss of ≥10%.

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.

Outcomes

Primary Outcome Measures

Change in Short Physical Performance Battery (SPPB)

short physical performance battery

Change in lean body mass

Bodpod

Secondary Outcome Measures

Full Information

NCT ID

NCT01715753

First Posted

October 25, 2012

Last Updated

December 10, 2018

Sponsor

Duke University

1. Study Identification

Unique Protocol Identification Number

NCT01715753

Brief Title

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

Acronym

MEASUR-UP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Weight Loss

Keywords

Function, Muscle mass

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

71 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Weight Loss Control

Arm Type

Active Comparator

Arm Description

Diet counseling and group education lessons. Subjects follow a calorie-reduction diet for a weight loss of ≥10%.

Arm Title

Weight Loss-High Protein

Arm Type

Experimental

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Protein supplementation

Intervention Description

> 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.

Intervention Type

Behavioral

Intervention Name(s)

Diet counseling and group education lessons

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Short Physical Performance Battery (SPPB)

Description

short physical performance battery

Time Frame

Baseline to 3 to 6 months

Title

Change in lean body mass

Description

Bodpod

Time Frame

Baseline to 3 and 6 months

Other Pre-specified Outcome Measures:

Title

Change in baseline lipids (classes, subclasses, participle size and number) at 6 months

Description

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.

Time Frame

Baseline to 6 months

Title

Changes in baseline GlycA at 6 months

Description

NMR-measured systemic inflammatory factor and a biomarker of CVD risk

Time Frame

Baseline to 6 months

Title

Change in baseline trimethylamine-N-oxide (TMAO) at 6 months

Description

TMAO is a metabolite produced from trimethylamine (TMA) containing nutrients. Nuclear magnetic resonance (NMR) spectroscopy assay was used for quantification of TMAO concentrations.

Time Frame

Baseline to 6 months

Title

Change in baseline betaine at 6 months

Description

Betaine was measured by 1H-nuclear magnetic resonance (NMR) spectroscopy using a Vantera® NMR Clinical Analyzer (LabCorp, Raleigh, NC).

Time Frame

Baseline to 6 months

Title

Change in baseline branched chain amino acids (BCAA) at 6 months

Description

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.

Time Frame

Baseline to 6 months

Title

Change in baseline Lipoprotein Insulin Resistance Index (LP-IR) scores at 6 months

Description

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.

Time Frame

Baseline to 6 months

Title

Change in baseline GFR at 6 months

Description

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.

Time Frame

Baseline to 6 months

Title

Change in baseline fasting glucose at 6 months

Description

Level of glucose in the blood after fasting for at least 8 hours

Time Frame

Baseline to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Connie W Bales, PhD, RD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

30810500

Citation

Porter Starr KN, Orenduff M, McDonald SR, Mulder H, Sloane R, Pieper CF, Bales CW. Influence of Weight Reduction and Enhanced Protein Intake on Biomarkers of Inflammation in Older Adults with Obesity. J Nutr Gerontol Geriatr. 2019 Jan-Mar;38(1):33-49. doi: 10.1080/21551197.2018.1564200. Epub 2019 Feb 27.

Results Reference

derived

PubMed Identifier

30498835

Citation

Payne ME, Porter Starr KN, Orenduff M, Mulder HS, McDonald SR, Spira AP, Pieper CF, Bales CW. Quality of Life and Mental Health in Older Adults with Obesity and Frailty: Associations with a Weight Loss Intervention. J Nutr Health Aging. 2018;22(10):1259-1265. doi: 10.1007/s12603-018-1127-0.

Results Reference

derived

PubMed Identifier

26786203

Citation

Porter Starr KN, Pieper CF, Orenduff MC, McDonald SR, McClure LB, Zhou R, Payne ME, Bales CW. Improved Function With Enhanced Protein Intake per Meal: A Pilot Study of Weight Reduction in Frail, Obese Older Adults. J Gerontol A Biol Sci Med Sci. 2016 Oct;71(10):1369-75. doi: 10.1093/gerona/glv210. Epub 2016 Jan 18.

Results Reference

derived

PubMed Identifier

25461495

Citation

McDonald SR, Porter Starr KN, Mauceri L, Orenduff M, Granville E, Ocampo C, Payne ME, Pieper CF, Bales CW. Meal-based enhancement of protein quality and quantity during weight loss in obese older adults with mobility limitations: rationale and design for the MEASUR-UP trial. Contemp Clin Trials. 2015 Jan;40:112-23. doi: 10.1016/j.cct.2014.11.010. Epub 2014 Nov 20.

Results Reference

derived

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

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