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

Weight Loss Clinical Trial

— MEASUR-UP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01715753
• Other study ID #: Pro00037110
• Secondary ID: 3834193
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: December 2014

Study information

• Verified date: March 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Weight Loss

Intervention

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.

Behavioral:
• Diet counseling and group education lessons
Individual and group diet counseling to achieve a >10% weight loss

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in baseline lipids (classes, subclasses, participle size and number) at 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.	Baseline to 6 months
Other	Changes in baseline GlycA at 6 months	NMR-measured systemic inflammatory factor and a biomarker of CVD risk	Baseline to 6 months
Other	Change in baseline trimethylamine-N-oxide (TMAO) at 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.	Baseline to 6 months
Other	Change in baseline betaine at 6 months	Betaine was measured by 1H-nuclear magnetic resonance (NMR) spectroscopy using a Vantera® NMR Clinical Analyzer (LabCorp, Raleigh, NC).	Baseline to 6 months
Other	Change in baseline branched chain amino acids (BCAA) at 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.	Baseline to 6 months
Other	Change in baseline Lipoprotein Insulin Resistance Index (LP-IR) scores at 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.	Baseline to 6 months
Other	Change in baseline GFR at 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.	Baseline to 6 months
Other	Change in baseline fasting glucose at 6 months	Level of glucose in the blood after fasting for at least 8 hours	Baseline to 6 months
Primary	Change in Short Physical Performance Battery (SPPB)	short physical performance battery	Baseline to 3 to 6 months
Primary	Change in lean body mass	Bodpod	Baseline to 3 and 6 months