A High Protein Weight Loss Intervention for Sarcopenic Obesity in Women
Completed · Not applicable
Conditions studied: Weight Loss, Obesity
In brief
The purpose of the trial is to assess the effects of combining regular, generous intakes of high quality protein (primarily from lean pork and other animal source proteins) with calorie restriction on functional status and lean muscle mass in frail, obese, women who participate in a 6 month intervention and 9 month intervention.
Key facts
- Study ID
- NCT02033655
- Run by
- Duke University
- People needed
- 105
- Starts
- 2014-03-01
- Expected to finish
- 2018-08-22
- Last updated by the study team
- 2019-01-08
Who can join
Age: 45 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Age 45+ 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.
Where it is running
- Duke Universtiy Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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