Comparison of Medical Nutritional Supplements

Comparison of Medical Nutritional Supplements With or Without AN777 in Elderly Men

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

Study Overview

• Status: Completed
• Conditions: Elderly
• Intervention / Treatment: Other: Oral medical nutritional supplement; Other: Experimental oral medical nutritional supplement with AN777

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in protein metabolism	Via amino acid tracers	Between baseline and 8 hours later

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intracellular signaling pathway metabolism	Via Amino acid tracers and protein phosphorylation measurements	Between Baseline and 8 hours later

Collaborators and Investigators

• Sponsor: Abbott Nutrition

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: November 23, 2011
• First Submitted That Met QC Criteria: November 30, 2011
• First Posted (Estimate): December 2, 2011

Study Record Updates

• Last Update Posted (Estimate): January 31, 2013
• Last Update Submitted That Met QC Criteria: January 30, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: BK96