Study of Protein Metabolism in Healthy Older Subjects

Study Overview
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Brief Summary
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This is a randomized, double-blinded, crossover study to evaluate muscle protein metabolism during fasting and feeding in healthy older subjects.

Official Title
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Study of Acute Muscle Protein Metabolism in Healthy Older Subjects

Conditions
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Malnutrition

Intervention / Treatment
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* Other: Experimental protein powder sachet
* Other: Control protein powder sachet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 60 and ≤ 75 years Body Mass Index (BMI) > 23.0 to < 30.0 Ability (with or without the aid of an assistive device) to climb a flight of 10 stairs or walk an equivalent of 1 city block without assistance Currently not participating in a formal exercise or training program and agrees to refrain from intense physical activity from screening through the completion of the study. Exclusion Criteria: Diagnosis of diabetes Active pursuit of weight loss Poorly controlled hypertension or hypotension Untreated hypothyroidism or hyperthyroidism Anemia or abnormally functioning kidneys or liver A significant cardiovascular event within ≤ 6 months; or stated history of congestive heart failure; or evidence of clinically active cardiovascular disease assessed during the screening EKG Peripheral arterial disease or other diseases that preclude proper limb blood flow Chronic, contagious, infectious disease Current infection or corticosteroid treatment within the last 3 months Clotting or bleeding disorders, stated history of Deep Vein Thrombosis (DVT) and/or a known hypercoagulable condition In condition deemed unsuitable for study based upon study physician assessment Surgery requiring >2 days of hospitalization in the last 3 weeks and/or planned elective surgery requiring >2 days of hospitalization during the course of the study Current active malignant disease or was treated within the last 6 months for cancer An amputee Obstruction of the gastrointestinal tract, inflammatory bowel disease, short bowel syndrome or other forms of gastrointestinal disease Diagnosed with, or has a history of severe dementia or delirium, eating disorder, history of significant neurological or psychiatric disorder, alcoholism, substance abuse Cannot refrain from taking High doses of fish oil, or omega-3 supplements, or high doses of vitamin D Medications/dietary supplements/herbals or substances that are considered anabolic, or reduce weight Any pulmonary anti-inflammatory medication or bronchodilators on the day of and 48 hours prior to study visits 1 and 2 NSAIDS or acetaminophen on the day of and 48 hours prior to study visits 1 and 2 Chronic use of nicotine Allergic or intolerant to any ingredient found in the study products

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Control protein powder sachet | Other: Control protein powder sachet<br>* mixed with 8 oz. water<br>|
| Experimental: Experimental<br>Experimental protein powder sachet | Other: Experimental protein powder sachet<br>* mixed with 8 oz. water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protein Metabolism | Study Visit 1 and Study Visit 2 | Change from - 1 to + 5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macrovascular Blood Flow | Study Visit 1 and Study Visit 2 | Change from -1 to +5 hours | 
| Glycemic Markers | Study Visit 1 and Study Visit 2 | Change from -1 to +5 hours | 
| Microvascular Blood Flow | Study Visit 1 and Study Visit 2 | Change from -1 to +5 hours |