NCT01483976CompletedPhase 3
Comparison of Medical Nutritional Supplements With or Without AN777 in Elderly Men
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Abbott Nutrition
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Change in protein metabolism
Study Overview
Brief Summary
The objective of this study is to verify changes in protein metabolism after ingesting a oral medical nutritional supplement.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to 90 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male and is ≥ 60 and ≤ 90 years of age.
- •Body Mass Index (BMI) > 20.0, but < 35.
- •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
- •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/1.73m
- •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.
- •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.
Arms & Interventions
Oral medical nutritional supplement without AN777
Active Comparator
orally over a three hour period
Intervention: Oral medical nutritional supplement (Other)
Experimental oral medical nutritional supplement with AN777
Experimental
orally over a three hour period
Intervention: Experimental oral medical nutritional supplement with AN777 (Other)
Outcomes
Primary Outcomes
Change in protein metabolism
Time Frame: Between baseline and 8 hours later
Via amino acid tracers
Secondary Outcomes
- Intracellular signaling pathway metabolism(Between Baseline and 8 hours later)
Investigators
Study Sites (1)
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