Evaluation of an Oral Nutritional Supplement Containing AN777

Sarcopenia Clinical Trial

Official title:

Evaluation of an Oral Nutritional Supplement Containing AN777 in Malnourished and Frail Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01191125
• Other study ID #: BK94
• Status: Completed
• Phase: Phase 3
• First received: August 27, 2010
• Last updated: March 5, 2013
• Start date: February 2011
• Est. completion date: September 2012

Study information

• Verified date: March 2013
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardGermany: Ethics CommissionBelgium: Ethics CommitteeMexico: Ethics CommitteeSpain: Ethics CommitteeSwitzerland: EthikkommissionItaly: Ethics CommitteeUnited Kingdom: Research Ethics CommitteePoland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 331
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malnutrition
• Sarcopenia

Intervention

Other:
• medical food with AN777
Two(220 mL)servings every day for six months
• oral nutritional formula
Two (220 mL) servings daily for six months

Locations

Country	Name	City	State
Belgium	ZNA St. Elisabeth	Antwerpen
Italy	Catholic University of Rome	Rome
Italy	University of Verona	Verona
Mexico	Althian - Research Management Center	Monterrey	Nuevo Leon
Poland	NSZOZ Unica CR	Dabrowka
Poland	Mazowieckie Centrum Badan Klinicznych S.C..	Grodzisk Mazowiecki
Poland	Tomasz Dabrowski Slaskie Centrum	Katowice
Poland	Centrum Medyczne Osteomed	Warszawa
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital General Universitario Gregorio Maranon	Madrid
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Insituto Provincial de Rehabilitacion	Madrid
Switzerland	University Hospitals, WHO	Geneva
United Kingdom	Imperial College Healthcare NHS Trust	Charing Cross	London
United Kingdom	University of Nottingham Medical School,	Nottingham
United States	Provident Clinical Research	Addison	Illinois
United States	University of Alabama, Brimingham	Birmington	Alabama
United States	Radiant Research, Inc	Chicago	Illinois
United States	Radiant Research, Inc	Cincinnati	Ohio
United States	Radiant Research, Inc.	Dallas	Texas
United States	Creighton University	Omaha	Nebraska
United States	Radiant Research, Inc.	Overland Park	Kansas
United States	Radiant Research, Inc	Santa Rosa	California

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Countries where clinical trial is conducted

United States,  Belgium,  Italy,  Mexico,  Poland,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee extensor strength		Six months	No
Secondary	Leg muscle mass		Six months	No
Secondary	Body Weight		Six months	No
Secondary	Functional measures		Six months	No