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Comparison of Medical Nutritional Supplements

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01483976
First received: November 23, 2011
Last updated: January 30, 2013
Last verified: January 2013
History of Changes
  Purpose

The objective of this study is to verify changes in protein metabolism after ingesting a oral medical nutritional supplement.


Condition Intervention Phase
Elderly
 Other: Oral medical nutritional supplement
Other: Experimental oral medical nutritional supplement with AN777
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Medical Nutritional Supplements With or Without AN777 in Elderly Men

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Change in protein metabolism [ Time Frame: Between baseline and 8 hours later ] [ Designated as safety issue: No ]
    Via amino acid tracers


Secondary Outcome Measures:
  • Intracellular signaling pathway metabolism [ Time Frame: Between Baseline and 8 hours later ] [ Designated as safety issue: No ]
    Via Amino acid tracers and protein phosphorylation measurements


Enrollment: 27
Study Start Date: October 2011
Study Completion Date: May 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oral medical nutritional supplement without AN777
orally over a three hour period
 Other: Oral medical nutritional supplement
orally over a three hour period
Experimental: Experimental oral medical nutritional supplement with AN777
orally over a three hour period
 Other: Experimental oral medical nutritional supplement with AN777
orally over a three hour period

  Eligibility

Ages Eligible for Study:   60 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and is ≥ 60 and ≤ 90 years of age.
  • Body Mass Index (BMI) > 20.0, but < 35.0.
  • Ability to climb a flight of 10 stairs or walk an equivalent of city block without help within the 3 months prior to enrollment.
  • Refrain from taking any dose of NSAIDs or acetaminophen on the day of and 24 hours prior to Visit 2 and Visit 3.
  • Refrain from using any pulmonary maintenance medications on the days of Visit 2 and Visit
  • Refrain from intense physical activity between visits.

Exclusion Criteria:

  • Systemic corticosteroids within the 3 months prior to enrollment.
  • Blood thinner or anticoagulant medication within 1 week prior to enrollment.
  • Glomerular filtration rate (eGFR) of < 40 mL/min/1.73m2.
  • Antibiotics within 1 week prior to enrollment.
  • Major surgery less than 3 months prior to enrollment in the study.
  • Active malignant disease or treated within the last 6 months for cancer.
  • Immunodeficiency disorder.
  • Diabetes
  • Myocardial infarction 3 months prior to enrollment.
  • Chronic obstructive pulmonary disease
  • History of allergy to any of the ingredients in the study products.
  • Conditions precluding ingestion or absorption of the study product, inflammatory bowel disease, short bowel syndrome, or other major gastrointestinal disease.
  • Dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, or any other psychological condition.
  • Pursuing weight loss or weight gain.
  • Medications/dietary supplements/substances that could modulate metabolism or weight.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01483976

Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Vikkie Mustad, PhD Abbott Nutrition
  More Information

No publications provided

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01483976     History of Changes
Other Study ID Numbers: BK96
Study First Received: November 23, 2011
Last Updated: January 30, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 16, 2013