Evaluation of an Oral Nutritional Supplement Containing AN777

Completed · Phase 3

Conditions studied: Malnutrition, Sarcopenia

In brief

To evaluate the effect of an experimental oral nutritional supplement containing AN777 compared to another oral nutritional supplement in a malnourished, elderly population.

Key facts

Study ID

NCT01191125

Run by

Abbott Nutrition

People needed

331

Starts

2011-02-01

Expected to finish

2012-09-01

Last updated by the study team

2013-03-07

Who can join

Age: 65 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Alabama, Brimingham — Birmington, Alabama, United States
• Radiant Research, Inc — Santa Rosa, California, United States
• Provident Clinical Research — Addison, Illinois, United States
• Radiant Research, Inc — Chicago, Illinois, United States
• Radiant Research, Inc. — Overland Park, Kansas, United States
• Creighton University — Omaha, Nebraska, United States
• Radiant Research, Inc — Cincinnati, Ohio, United States
• Radiant Research, Inc. — Dallas, Texas, United States
• ZNA St. Elisabeth — Antwerp, Belgium
• Catholic University of Rome — Rome, Italy
• University of Verona — Verona, Italy
• Althian - Research Management Center — Monterrey, Nuevo León, Mexico
• NSZOZ Unica CR — Dąbrówka, Poland
• Mazowieckie Centrum Badan Klinicznych S.C.. — Grodzisk Mazowiecki, Poland
• Tomasz Dabrowski Slaskie Centrum — Katowice, Poland
• Centrum Medyczne Osteomed — Warsaw, Poland
• Hospital Clinic de Barcelona — Barcelona, Spain
• Hospital General Universitario Gregorio Maranon — Madrid, Spain
• Insituto Provincial de Rehabilitacion — Madrid, Spain
• Hospital Universitario Ramon y Cajal — Madrid, Spain
• University Hospitals, WHO — Geneva, Switzerland
• Imperial College Healthcare NHS Trust — Charing Cross, London, United Kingdom
• University of Nottingham Medical School, — Nottingham, United Kingdom

Full record on ClinicalTrials.gov

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