Clinical trial NCT01715753: Measuring Eating, Activity and Strength: Understanding the Response -Using Protein
Official title: Does Enhanced Protein Intake Preserve Function and Lean Muscle Mass During Weight Reduction in Frail, Obese Older Adults?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Keywords: Function
Muscle mass
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2012-10-29
Enrollment: 71
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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)


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.

Primary outcomes:
measure: Change in Short Physical Performance Battery (SPPB)
timeFrame: Baseline to 3 to 6 months
measure: Change in lean body mass
timeFrame: Baseline to 3 and 6 months
Secondary outcomes:
Other outcomes:
measure: Change in baseline lipids (classes, subclasses, participle size and number) at 6 months
timeFrame: Baseline to 6 months
measure: Changes in baseline GlycA at 6 months
timeFrame: Baseline to 6 months
measure: Change in baseline trimethylamine-N-oxide (TMAO) at 6 months
timeFrame: Baseline to 6 months
measure: Change in baseline betaine at 6 months
timeFrame: Baseline to 6 months
measure: Change in baseline branched chain amino acids (BCAA) at 6 months
timeFrame: Baseline to 6 months
measure: Change in baseline Lipoprotein Insulin Resistance Index (LP-IR) scores at 6 months
timeFrame: Baseline to 6 months
measure: Change in baseline GFR at 6 months
timeFrame: Baseline to 6 months
measure: Change in baseline fasting glucose at 6 months
timeFrame: Baseline to 6 months
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Connie W Bales, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.