Measuring Eating, Activity and Strength: Understanding the Response -Using Protein
NCT ID: NCT01715753
Last Updated: 2018-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
71 participants
INTERVENTIONAL
2012-09-30
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Weight Loss Control
Diet counseling and group education lessons. Subjects follow a calorie-reduction diet for a weight loss of ≥10%.
Diet counseling and group education lessons
Individual and group diet counseling to achieve a \>10% weight loss
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.
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.
Interventions
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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.
Diet counseling and group education lessons
Individual and group diet counseling to achieve a \>10% weight loss
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
60 Years
ALL
No
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Connie W Bales, PhD, RD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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3834193
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Pro00037110
Identifier Type: -
Identifier Source: org_study_id