Comparison of Medical Nutritional Supplements

Phase 3

Completed

• Conditions: Elderly
• Interventions: Other: Experimental oral medical nutritional supplement with AN777; Other: Oral medical nutritional supplement

• Registration Number: NCT01483976
• Lead Sponsor: Abbott Nutrition

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-11-23
• Study First Submitted QC: 2011-11-30
• Study First Posted: 2011-12-02
• Primary Completion: 2012-03
• Study Completion: 2012-05
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-30
• Last Update Posted: 2013-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental oral medical nutritional supplement with AN777	Experimental oral medical nutritional supplement with AN777	orally over a three hour period
Oral medical nutritional supplement without AN777	Oral medical nutritional supplement	orally over a three hour period

Primary Outcome Measures

Name	Time	Method
Change in protein metabolism	Between baseline and 8 hours later	Via amino acid tracers

Secondary Outcome Measures

Name	Time	Method
Intracellular signaling pathway metabolism	Between Baseline and 8 hours later	Via Amino acid tracers and protein phosphorylation measurements

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States