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Evaluation of an Oral Nutritional Supplement Containing AN777

Primary Purpose

Malnutrition, Sarcopenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
medical food with AN777
oral nutritional formula
Sponsored by
Abbott Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama, Brimingham
  • Radiant Research, Inc
  • Provident Clinical Research
  • Radiant Research, Inc
  • Radiant Research, Inc.
  • Creighton University
  • Radiant Research, Inc
  • Radiant Research, Inc.
  • ZNA St. Elisabeth
  • Catholic University of Rome
  • University of Verona
  • Althian - Research Management Center
  • NSZOZ Unica CR
  • Mazowieckie Centrum Badan Klinicznych S.C..
  • Tomasz Dabrowski Slaskie Centrum
  • Centrum Medyczne Osteomed
  • Hospital Clinic de Barcelona
  • Hospital General Universitario Gregorio Maranon
  • Insituto Provincial de Rehabilitacion
  • Hospital Universitario Ramon y Cajal
  • University Hospitals, WHO
  • Imperial College Healthcare NHS Trust
  • University of Nottingham Medical School,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

medical food with AN777

oral nutritional formula

Arm Description

Outcomes

Primary Outcome Measures

Knee extensor strength

Secondary Outcome Measures

Leg muscle mass
Body Weight
Functional measures

Full Information

First Posted
August 27, 2010
Last Updated
March 5, 2013
Sponsor
Abbott Nutrition
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1. Study Identification

Unique Protocol Identification Number
NCT01191125
Brief Title
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

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Nutrition

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Sarcopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
331 (Actual)

8. Arms, Groups, and Interventions

Arm Title
medical food with AN777
Arm Type
Experimental
Arm Title
oral nutritional formula
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
medical food with AN777
Intervention Description
Two(220 mL)servings every day for six months
Intervention Type
Other
Intervention Name(s)
oral nutritional formula
Intervention Description
Two (220 mL) servings daily for six months
Primary Outcome Measure Information:
Title
Knee extensor strength
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Leg muscle mass
Time Frame
Six months
Title
Body Weight
Time Frame
Six months
Title
Functional measures
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vikkie Mustad, PhD
Organizational Affiliation
Abbott Nutrition
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama, Brimingham
City
Birmington
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Radiant Research, Inc
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95405
Country
United States
Facility Name
Provident Clinical Research
City
Addison
State/Province
Illinois
ZIP/Postal Code
60101
Country
United States
Facility Name
Radiant Research, Inc
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654
Country
United States
Facility Name
Radiant Research, Inc.
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66202
Country
United States
Facility Name
Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68178
Country
United States
Facility Name
Radiant Research, Inc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
Radiant Research, Inc.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
ZNA St. Elisabeth
City
Antwerpen
Country
Belgium
Facility Name
Catholic University of Rome
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
University of Verona
City
Verona
ZIP/Postal Code
37126
Country
Italy
Facility Name
Althian - Research Management Center
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64060
Country
Mexico
Facility Name
NSZOZ Unica CR
City
Dabrowka
ZIP/Postal Code
62-069
Country
Poland
Facility Name
Mazowieckie Centrum Badan Klinicznych S.C..
City
Grodzisk Mazowiecki
ZIP/Postal Code
05-825
Country
Poland
Facility Name
Tomasz Dabrowski Slaskie Centrum
City
Katowice
ZIP/Postal Code
40-084
Country
Poland
Facility Name
Centrum Medyczne Osteomed
City
Warszawa
ZIP/Postal Code
02-241
Country
Poland
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Insituto Provincial de Rehabilitacion
City
Madrid
ZIP/Postal Code
28028
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
University Hospitals, WHO
City
Geneva
Country
Switzerland
Facility Name
Imperial College Healthcare NHS Trust
City
Charing Cross
State/Province
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
University of Nottingham Medical School,
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27780567
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.
Results Reference
derived
PubMed Identifier
25923603
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.
Results Reference
derived

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Evaluation of an Oral Nutritional Supplement Containing AN777

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