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To evaluate the effect of an experimental oral nutritional supplement containing AN777 compared to another oral nutritional supplement in a malnourished, elderly population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| medical food with AN777 | Experimental |
| |
| oral nutritional formula | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| medical food with AN777 | Other | Two(220 mL)servings every day for six months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Knee extensor strength | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Leg muscle mass | Six months | |
| Body Weight | Six months | |
| Functional measures |
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Inclusion Criteria:
Subject (male or female) is > or equal to 65 and < or equal to 90 years of age
Subject is ambulatory
Subject has a Subjective Global Assessment of B or C
Subject has gait speed <0.8 m/s AND/OR low hand-grip strength
Subject has Class 1 or Class 2 sarcopenia
Subject agrees to refrain from starting a resistance exercise program
Exclusion Criteria:
Subject has type 1 or type 2 diabetes
Subject has inflammatory disease with elevated high sensitivity C-reactive protein
Subject has renal function impairment
Subject reports gastrointestinal disorder (severe chronic diarrhea, nausea, vomiting) that would preclude ingestion of the study product; an obstruction of the gastrointestinal tract, inflammatory bowel disease; short bowel syndrome or other major gastrointestinal disease
Subject reports of current active malignant disease or other significant medical diagnoses.
Subject reports a history of allergy to any of the ingredients in the study products
Subject reports currently taking medications/dietary supplements/substances that could profoundly modulate metabolism or weight.
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| Name | Affiliation | Role |
|---|---|---|
| Vikkie Mustad, PhD | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama, Brimingham | Birmington | Alabama | 35294 | United States | ||
| Radiant Research, Inc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27780567 | Derived | Cramer JT, Cruz-Jentoft AJ, Landi F, Hickson M, Zamboni M, Pereira SL, Hustead DS, Mustad VA. Impacts of High-Protein Oral Nutritional Supplements Among Malnourished Men and Women with Sarcopenia: A Multicenter, Randomized, Double-Blinded, Controlled Trial. J Am Med Dir Assoc. 2016 Nov 1;17(11):1044-1055. doi: 10.1016/j.jamda.2016.08.009. | |
| 25923603 |
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| oral nutritional formula |
| Other |
Two (220 mL) servings daily for six months |
|
| Six months |
| Santa Rosa |
| California |
| 95405 |
| United States |
| Provident Clinical Research | Addison | Illinois | 60101 | United States |
| Radiant Research, Inc | Chicago | Illinois | 60654 | United States |
| Radiant Research, Inc. | Overland Park | Kansas | 66202 | United States |
| Creighton University | Omaha | Nebraska | 68178 | United States |
| Radiant Research, Inc | Cincinnati | Ohio | 45249 | United States |
| Radiant Research, Inc. | Dallas | Texas | 75231 | United States |
| ZNA St. Elisabeth | Antwerp | Belgium |
| Catholic University of Rome | Rome | 00168 | Italy |
| University of Verona | Verona | 37126 | Italy |
| Althian - Research Management Center | Monterrey | Nuevo León | 64060 | Mexico |
| NSZOZ Unica CR | Dąbrówka | 62-069 | Poland |
| Mazowieckie Centrum Badan Klinicznych S.C.. | Grodzisk Mazowiecki | 05-825 | Poland |
| Tomasz Dabrowski Slaskie Centrum | Katowice | 40-084 | Poland |
| Centrum Medyczne Osteomed | Warsaw | 02-241 | Poland |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | 28007 | Spain |
| Insituto Provincial de Rehabilitacion | Madrid | 28028 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| University Hospitals, WHO | Geneva | Switzerland |
| Imperial College Healthcare NHS Trust | Charing Cross | London | W6 8RF | United Kingdom |
| University of Nottingham Medical School, | Nottingham | NG7 2UH | United Kingdom |
| Hickson M. Nutritional interventions in sarcopenia: a critical review. Proc Nutr Soc. 2015 Nov;74(4):378-86. doi: 10.1017/S0029665115002049. Epub 2015 Apr 29. |
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
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