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

NCT01715753 | Completed DMC

• 2 other identifiers: Pro000371103834193
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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)

Conditions

Weight Loss

Keywords

Function; Muscle mass

Outcome Measures

Primary Outcomes (2)

• Change in Short Physical Performance Battery (SPPB)

  short physical performance battery

  Baseline to 3 to 6 months

• Change in lean body mass

  Bodpod

  Baseline to 3 and 6 months

Other Outcomes (8)

• Change in baseline lipids (classes, subclasses, participle size and number) at 6 months

  Baseline to 6 months

• Changes in baseline GlycA at 6 months

  Baseline to 6 months

• Change in baseline trimethylamine-N-oxide (TMAO) at 6 months

  Baseline to 6 months

Study Arms (2)

Weight Loss Control

ACTIVE COMPARATOR

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

Weight Loss-High Protein

EXPERIMENTAL

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

Interventions

Protein supplementation DIETARY_SUPPLEMENT

\> 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.

Weight Loss-High Protein

Diet counseling and group education lessons BEHAVIORAL

Individual and group diet counseling to achieve a \>10% weight loss

Weight Loss Control

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (4)

• 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.

  PMID: 30810500 DERIVED

• 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.

  PMID: 30498835 DERIVED

• 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.

  PMID: 26786203 DERIVED

• 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.

  PMID: 25461495 DERIVED

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Connie W Bales, PhD, RD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2012
• First Posted: October 29, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 12, 2018

Record last verified: 2018-03

Locations

US (1)