Comparison of Medical Nutritional Supplements

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

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

Conditions
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Elderly

Intervention / Treatment
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* Other: Oral medical nutritional supplement
* Other: Experimental oral medical nutritional supplement with AN777


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral medical nutritional supplement without AN777<br>orally over a three hour period | Other: Oral medical nutritional supplement<br>* orally over a three hour period<br>|
| Experimental: Experimental oral medical nutritional supplement with AN777<br>orally over a three hour period | Other: Experimental oral medical nutritional supplement with AN777<br>* orally over a three hour period<br>|

What is the study measuring?
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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 |