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

Sponsor

Duke University (Other)

Overall Status

Completed

CT.gov ID

NCT01715753

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

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)

Condition or Disease	Intervention/Treatment	Phase
Weight Loss	Dietary Supplement: Protein supplementation Behavioral: Diet counseling and group education lessons	N/A

Study Design

Study Type:

Interventional

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 :

Sep 1, 2012

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in Short Physical Performance Battery (SPPB) [Baseline to 3 to 6 months]
short physical performance battery
Change in lean body mass [Baseline to 3 and 6 months]
Bodpod

Other Outcome Measures

Change in baseline lipids (classes, subclasses, participle size and number) at 6 months [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.
Changes in baseline GlycA at 6 months [Baseline to 6 months]
NMR-measured systemic inflammatory factor and a biomarker of CVD risk
Change in baseline trimethylamine-N-oxide (TMAO) at 6 months [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.
Change in baseline betaine at 6 months [Baseline to 6 months]
Betaine was measured by 1H-nuclear magnetic resonance (NMR) spectroscopy using a Vantera® NMR Clinical Analyzer (LabCorp, Raleigh, NC).
Change in baseline branched chain amino acids (BCAA) at 6 months [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.
Change in baseline Lipoprotein Insulin Resistance Index (LP-IR) scores at 6 months [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.
Change in baseline GFR at 6 months [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.
Change in baseline fasting glucose at 6 months [Baseline to 6 months]
Level of glucose in the blood after fasting for at least 8 hours

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Duke University

ClinicalTrials.gov Identifier:

NCT01715753

Other Study ID Numbers:

Pro00037110
3834193

First Posted:

Oct 29, 2012

Last Update Posted:

Dec 12, 2018

Last Verified:

Mar 1, 2018

Keywords provided by Duke University

Function

Muscle mass

Additional relevant MeSH terms:

Weight Loss

Study Results

No Results Posted as of Dec 12, 2018