Durham, North Carolina 27710

  • Weight Loss

Purpose:

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)


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.


NCT ID:

NCT01715753


Primary Contact:

Principal Investigator
Connie W Bales, PhD, RD
Duke University


Backup Contact:

N/A


Location Contact:

Durham, North Carolina 27710
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 16, 2021

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