Evaluation of an Oral Nutritional Supplement Containing AN777
Status and phase
Conditions
Treatments
Details and patient eligibility
About
To evaluate the effect of an experimental oral nutritional supplement containing AN777 compared to another oral nutritional supplement in a malnourished, elderly population.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
331 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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