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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Nutrition Disorders
Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014