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Evaluation of an Oral Nutritional Supplement Containing AN777

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01191125
Recruitment Status : Completed
First Posted : August 30, 2010
Last Update Posted : March 7, 2013
Information provided by (Responsible Party):
Abbott Nutrition

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

Condition or disease Intervention/treatment Phase
Malnutrition Sarcopenia Other: medical food with AN777 Other: oral nutritional formula Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 331 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of an Oral Nutritional Supplement Containing AN777 in Malnourished and Frail Subjects
Study Start Date : February 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: medical food with AN777 Other: medical food with AN777
Two(220 mL)servings every day for six months

Active Comparator: oral nutritional formula Other: oral nutritional formula
Two (220 mL) servings daily for six months

Primary Outcome Measures :
  1. Knee extensor strength [ Time Frame: Six months ]

Secondary Outcome Measures :
  1. Leg muscle mass [ Time Frame: Six months ]
  2. Body Weight [ Time Frame: Six months ]
  3. Functional measures [ Time Frame: Six months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01191125

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Sponsors and Collaborators
Abbott Nutrition
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Study Chair: Vikkie Mustad, PhD Abbott Nutrition

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Abbott Nutrition Identifier: NCT01191125     History of Changes
Other Study ID Numbers: BK94
First Posted: August 30, 2010    Key Record Dates
Last Update Posted: March 7, 2013
Last Verified: March 2013
Additional relevant MeSH terms:
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Nutrition Disorders
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathological Conditions, Anatomical
Signs and Symptoms