Evaluation of an Oral Nutritional Supplement Containing AN777

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01191125
First received: August 27, 2010
Last updated: March 5, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Malnutrition
Sarcopenia
Other: medical food with AN777
Other: oral nutritional formula
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of an Oral Nutritional Supplement Containing AN777 in Malnourished and Frail Subjects

Resource links provided by NLM:


Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Knee extensor strength [ Time Frame: Six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Leg muscle mass [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Body Weight [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Functional measures [ Time Frame: Six months ] [ Designated as safety issue: No ]

Enrollment: 331
Study Start Date: February 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   65 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01191125

  Show 23 Study Locations
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Vikkie Mustad, PhD Abbott Nutrition
  More Information

No publications provided

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01191125     History of Changes
Other Study ID Numbers: BK94
Study First Received: August 27, 2010
Last Updated: March 5, 2013
Health Authority: United States: Institutional Review Board
Germany: Ethics Commission
Belgium: Ethics Committee
Mexico: Ethics Committee
Spain: Ethics Committee
Switzerland: Ethikkommission
Italy: Ethics Committee
United Kingdom: Research Ethics Committee
Poland: Ethics Committee

Additional relevant MeSH terms:
Malnutrition
Sarcopenia
Nutrition Disorders
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014