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
|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|
|Intervention Model:||Parallel Assignment|
|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|
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.
- Change in Short Physical Performance Battery (SPPB) [ Time Frame: Baseline to 3 to 6 months ]short physical performance battery
- Change in lean body mass [ Time Frame: Baseline to 3 and 6 months ]Bodpod
- 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.
- Changes in baseline GlycA at 6 months [ Time Frame: 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 [ 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.
- 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).
- 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.
- 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.
- 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.
- 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
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
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Connie W Bales, PhD, RD||Duke University|