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Comparison of Medical Nutritional Supplements

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ClinicalTrials.gov Identifier: NCT01483976
Recruitment Status : Completed
First Posted : December 2, 2011
Last Update Posted : January 31, 2013
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition

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

Condition or disease Intervention/treatment Phase
Elderly Other: Oral medical nutritional supplement Other: Experimental oral medical nutritional supplement with AN777 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Medical Nutritional Supplements With or Without AN777 in Elderly Men
Study Start Date : October 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change in protein metabolism [ Time Frame: Between baseline and 8 hours later ]
    Via amino acid tracers


Secondary Outcome Measures :
  1. Intracellular signaling pathway metabolism [ Time Frame: Between Baseline and 8 hours later ]
    Via Amino acid tracers and protein phosphorylation measurements



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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Senior)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01483976     History of Changes
Other Study ID Numbers: BK96
First Posted: December 2, 2011    Key Record Dates
Last Update Posted: January 31, 2013
Last Verified: January 2013