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The study will evaluate the effects of oral nutritional supplements (ONS) on attenuating the lean body mass (LBM) loss that occurs after bed rest.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control ONS | Active Comparator | ONS without AN777 |
|
| Investigational ONS | Experimental | ONS containing AN777 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONS without AN777 | Other | 2 servings a day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Total lean body mass | Change from baseline | Baseline to Study Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Hand-grip strength | Change from baseline | Baseline, Study Day 10, Study Week 6 and 12 |
| Short Physical Performance Battery (SPPB) | Change from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Owen Kelly, Ph.D | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences (UAMS) | Little Rock | Arkansas | 72205-7199 | United States | ||
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| ONS containing AN777 | Other | 2 servings a day |
|
|
| Baseline, Study Day 10, Study Week 6 and 12 |
| Isokinetic leg strength | Change from baseline | Baseline, Study Day 10 and Study Week 12 |
| Body Mass Index (BMI) | Calculated BMI = weight/height2 (kg/m2). | Screening Visits 1 and 3; Baseline; Study Days 2, 4, 6, 8 and 10; Study Weeks 3, 6, 9 and 12 |
| Lower extremity lean mass | Measured by DXA; Change from baseline | Baseline, Study Day 10, Study Weeks 6 and 12 |
| Florida Hospital Translational Research Institute for Metabolism and Diabetes |
| Orlando |
| Florida |
| 32804 |
| United States |
| Center of Translational Research in Aging & Longevity | College Station | Texas | 77843-4253 | United States |