Evaluation of an Oral Nutritional Supplement Containing AN777

NCT01191125 | Completed Phase 3 DMC

• 1 other identifier: BK94
• Study Type: interventional
• Target: 331
• Locations: 8 countries
• Sites: 23

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.

Conditions

Malnutrition; Sarcopenia

Outcome Measures

Primary Outcomes (1)

• Knee extensor strength

  Six months

Secondary Outcomes (3)

• Leg muscle mass

  Six months

• Body Weight

  Six months

• Functional measures

  Six months

Study Arms (2)

medical food with AN777

EXPERIMENTAL

Other: medical food with AN777

oral nutritional formula

ACTIVE COMPARATOR

Other: oral nutritional formula

Interventions

medical food with AN777 OTHER

Two(220 mL)servings every day for six months

medical food with AN777

oral nutritional formula OTHER

Two (220 mL) servings daily for six months

oral nutritional formula

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (23)

University of Alabama, Brimingham

Birmington, Alabama, 35294, United States

Location

Radiant Research, Inc

Santa Rosa, California, 95405, United States

Location

Provident Clinical Research

Addison, Illinois, 60101, United States

Location

Radiant Research, Inc

Chicago, Illinois, 60654, United States

Location

Radiant Research, Inc.

Overland Park, Kansas, 66202, United States

Location

Creighton University

Omaha, Nebraska, 68178, United States

Location

Radiant Research, Inc

Cincinnati, Ohio, 45249, United States

Location

Radiant Research, Inc.

Dallas, Texas, 75231, United States

Location

ZNA St. Elisabeth

Antwerp, Belgium

Location

Catholic University of Rome

Rome, 00168, Italy

Location

University of Verona

Verona, 37126, Italy

Location

Althian - Research Management Center

Monterrey, Nuevo León, 64060, Mexico

Location

NSZOZ Unica CR

Dąbrówka, 62-069, Poland

Location

Mazowieckie Centrum Badan Klinicznych S.C..

Grodzisk Mazowiecki, 05-825, Poland

Location

Tomasz Dabrowski Slaskie Centrum

Katowice, 40-084, Poland

Location

Centrum Medyczne Osteomed

Warsaw, 02-241, Poland

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

Insituto Provincial de Rehabilitacion

Madrid, 28028, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

University Hospitals, WHO

Geneva, Switzerland

Location

Imperial College Healthcare NHS Trust

Charing Cross, London, W6 8RF, United Kingdom

Location

University of Nottingham Medical School,

Nottingham, NG7 2UH, United Kingdom

Location

Related Publications (2)

• Cramer JT, Cruz-Jentoft AJ, Landi F, Hickson M, Zamboni M, Pereira SL, Hustead DS, Mustad VA. Impacts of High-Protein Oral Nutritional Supplements Among Malnourished Men and Women with Sarcopenia: A Multicenter, Randomized, Double-Blinded, Controlled Trial. J Am Med Dir Assoc. 2016 Nov 1;17(11):1044-1055. doi: 10.1016/j.jamda.2016.08.009.

  PMID: 27780567 DERIVED

• Hickson M. Nutritional interventions in sarcopenia: a critical review. Proc Nutr Soc. 2015 Nov;74(4):378-86. doi: 10.1017/S0029665115002049. Epub 2015 Apr 29.

  PMID: 25923603 DERIVED

MeSH Terms

Conditions

Malnutrition; Sarcopenia

Condition Hierarchy (Ancestors)

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

Study Officials

• Vikkie Mustad, PhD

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2010
• First Posted: August 30, 2010
• Study Start: February 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: March 7, 2013

Record last verified: 2013-03

Locations

ME (1); PL (4); IT (2); ES (4); CH (1); BE (1); GB (2); US (8)