Evaluation of an Oral Nutritional Supplement Containing AN777

March 5, 2013 updated by: Abbott Nutrition

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

331

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium
        • ZNA St. Elisabeth
  • Italy
      • Rome, Italy, 00168
        • Catholic University of Rome
      • Verona, Italy, 37126
        • University of Verona
  • Mexico
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64060
        • Althian - Research Management Center
  • Poland
      • Dabrowka, Poland, 62-069
        • NSZOZ Unica CR
      • Grodzisk Mazowiecki, Poland, 05-825
        • Mazowieckie Centrum Badan Klinicznych S.C..
      • Katowice, Poland, 40-084
        • Tomasz Dabrowski Slaskie Centrum
      • Warszawa, Poland, 02-241
        • Centrum Medyczne Osteomed
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clínic de Barcelona
      • Madrid, Spain, 28034
        • Hospital Universitario Ramón y Cajal
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañón
      • Madrid, Spain, 28028
        • Insituto Provincial de Rehabilitacion
  • Switzerland
      • Geneva, Switzerland
        • University Hospitals, WHO
  • United Kingdom
      • Nottingham, United Kingdom, NG7 2UH
        • University of Nottingham Medical School,
    • London
      • Charing Cross, London, United Kingdom, W6 8RF
        • Imperial College Healthcare NHS Trust
  • United States
    • Alabama
      • Birmington, Alabama, United States, 35294
        • University of Alabama, Brimingham
    • California
      • Santa Rosa, California, United States, 95405
        • Radiant Research, Inc
    • Illinois
      • Addison, Illinois, United States, 60101
        • Provident Clinical Research
      • Chicago, Illinois, United States, 60654
        • Radiant Research, Inc
    • Kansas
      • Overland Park, Kansas, United States, 66202
        • Radiant Research, Inc.
    • Nebraska
      • Omaha, Nebraska, United States, 68178
        • Creighton University
    • Ohio
      • Cincinnati, Ohio, United States, 45249
        • Radiant Research, Inc
    • Texas
      • Dallas, Texas, United States, 75231
        • Radiant Research, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 90 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: medical food with AN777
Other: medical food with AN777
Two(220 mL)servings every day for six months
Active Comparator: oral nutritional formula
Other: oral nutritional formula
Two (220 mL) servings daily for six months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Knee extensor strength
Time Frame: Six months
Six months

Secondary Outcome Measures

Outcome Measure
Time Frame
Leg muscle mass
Time Frame: Six months
Six months
Body Weight
Time Frame: Six months
Six months
Functional measures
Time Frame: Six months
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Nutrition

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

August 27, 2010

First Submitted That Met QC Criteria

August 27, 2010

First Posted (Estimate)

August 30, 2010

Study Record Updates

Last Update Posted (Estimate)

March 7, 2013

Last Update Submitted That Met QC Criteria

March 5, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BK94

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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