Evaluation of an Oral Nutritional Supplement Containing AN777

Phase 3

Completed

• Conditions: Malnutrition; Sarcopenia

• Registration Number: NCT01191125
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-27
• Study First Submitted QC: 2010-08-27
• Study First Posted: 2010-08-30
• Study Start: 2011-02
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-05
• Last Update Posted: 2013-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 331

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Knee extensor strength	Six months

Secondary Outcome Measures

Name	Time	Method
Functional measures	Six months
Leg muscle mass	Six months
Body Weight	Six months

Trial Locations

Locations (20)

University of Alabama, Brimingham; 🇺🇸 Birmington, Alabama, United States

Radiant Research, Inc; 🇺🇸 Cincinnati, Ohio, United States

Provident Clinical Research; 🇺🇸 Addison, Illinois, United States

Radiant Research, Inc.; 🇺🇸 Dallas, Texas, United States

Creighton University; 🇺🇸 Omaha, Nebraska, United States

ZNA St. Elisabeth; 🇧🇪 Antwerpen, Belgium

Catholic University of Rome; 🇮🇹 Rome, Italy

University of Verona; 🇮🇹 Verona, Italy

Althian - Research Management Center; 🇲🇽 Monterrey, Nuevo Leon, Mexico

NSZOZ Unica CR; 🇵🇱 Dabrowka, Poland

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