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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014