Evaluation of an Oral Nutritional Supplement Containing AN777

Phase 3

Completed

• Conditions: Malnutrition; Sarcopenia
• Interventions: Other: medical food with AN777; Other: oral nutritional formula

• 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

Arm && Interventions

Group	Intervention	Description
medical food with AN777	medical food with AN777	-
oral nutritional formula	oral nutritional formula	-

Primary Outcome Measures

Name	Time	Method
Knee extensor strength	Six months

Secondary Outcome Measures

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

Trial Locations

Locations (20)

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

University Hospitals, WHO; 🇨🇭 Geneva, Switzerland

Hospital Universitario Ramon y Cajal; 🇪🇸 Madrid, Spain

University of Nottingham Medical School,; 🇬🇧 Nottingham, United Kingdom

Imperial College Healthcare NHS Trust; 🇬🇧 Charing Cross, London, United Kingdom

Insituto Provincial de Rehabilitacion; 🇪🇸 Madrid, Spain

Catholic University of Rome; 🇮🇹 Rome, Italy

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

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

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

University of Verona; 🇮🇹 Verona, Italy

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

Creighton University; 🇺🇸 Omaha, Nebraska, United States

ZNA St. Elisabeth; 🇧🇪 Antwerpen, Belgium

NSZOZ Unica CR; 🇵🇱 Dabrowka, Poland

Mazowieckie Centrum Badan Klinicznych S.C..; 🇵🇱 Grodzisk Mazowiecki, Poland

Hospital General Universitario Gregorio Maranon; 🇪🇸 Madrid, Spain

Centrum Medyczne Osteomed; 🇵🇱 Warszawa, Poland

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain

Tomasz Dabrowski Slaskie Centrum; 🇵🇱 Katowice, Poland