Clinical trial NCT01191125: Evaluation of an Oral Nutritional Supplement Containing AN777
Official title: Evaluation of an Oral Nutritional Supplement Containing AN777 in Malnourished and Frail Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malnutrition
Sarcopenia
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2010-08-30
Enrollment: 331
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Knee extensor strength
timeFrame: Six months
Secondary outcomes:
measure: Leg muscle mass
timeFrame: Six months
measure: Body Weight
timeFrame: Six months
measure: Functional measures
timeFrame: Six months
Other outcomes:
Locations:
city: Birmington
country: United States
facility: University of Alabama, Brimingham
state: Alabama
city: Santa Rosa
country: United States
facility: Radiant Research, Inc
state: California
city: Addison
country: United States
facility: Provident Clinical Research
state: Illinois
city: Chicago
country: United States
facility: Radiant Research, Inc
state: Illinois
city: Overland Park
country: United States
facility: Radiant Research, Inc.
state: Kansas
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
city: Cincinnati
country: United States
facility: Radiant Research, Inc
state: Ohio
city: Dallas
country: United States
facility: Radiant Research, Inc.
state: Texas
city: Antwerpen
country: Belgium
facility: ZNA St. Elisabeth
city: Rome
country: Italy
facility: Catholic University of Rome
city: Verona
country: Italy
facility: University of Verona
city: Monterrey
country: Mexico
facility: Althian - Research Management Center
state: Nuevo Leon
city: Dabrowka
country: Poland
facility: NSZOZ Unica CR
city: Grodzisk Mazowiecki
country: Poland
facility: Mazowieckie Centrum Badan Klinicznych S.C..
city: Katowice
country: Poland
facility: Tomasz Dabrowski Slaskie Centrum
city: Warszawa
country: Poland
facility: Centrum Medyczne Osteomed
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Insituto Provincial de Rehabilitacion
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Geneva
country: Switzerland
facility: University Hospitals, WHO
city: Charing Cross
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
state: London
city: Nottingham
country: United Kingdom
facility: University of Nottingham Medical School,
Study officials:
affiliation: Abbott Nutrition
name: Vikkie Mustad, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.