Evaluation of an Oral Nutritional Supplement on Lean Body Mass in Healthy Older Subjects.

Study Overview
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Brief Summary
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The study will evaluate the effects of oral nutritional supplements (ONS) on attenuating the lean body mass (LBM) loss that occurs after bed rest.

Official Title
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Evaluation of a Complete Oral Nutritional Supplement on Lean Body Mass in Healthy Older Subjects During Bed Rest and Recovery.

Conditions
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Healthy

Intervention / Treatment
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* Other: ONS without AN777
* Other: ONS containing AN777


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 60 to ≤ 79 years Body Mass Index (BMI) >20 but ≤ 35 kg/m2. Short Physical Performance Battery (SPPB) score of > 9 (fully functional with no mobility limitations). Triacylglyceride (TAG) level is ≤ 250 mg/dl, LDL cholesterol is ≤ 155 mg/dl, total cholesterol level is ≤ 250 mg/dl. Compliance with the various activity levels required for this study. Ankle brachial index within the normal range, between 1 and 1.4. Physical activity score within the 2008 Guidelines for Americans. Normal-good handgrip strength. Exclusion Criteria: Type I or Type II Diabetes Mellitus. Fasting blood glucose level of >115 mg/dl. Major surgery, less than 6 weeks prior to enrollment in the study, or subject has planned elective surgery requiring 2 or more days of hospitalization. History of pressure ulcers. Stated history of Deep Vein Thrombosis (DVT), recent elevated D-dimer test, a positive ultrasound for DVT, pulmonary embolism, carotid atherosclerosis, transient ischemic attack (TIA), or stated hypercoaguable condition, or other clotting or bleeding disorders, or is currently prescribed blood thinners. Varicose veins that would result in significant discomfort while wearing TED hose and/or SCD. Stated autoimmune disease or active malignant disease. Estimated glomerular filtration rate is < 50ml/min/1.73m2. Current significantly impaired liver function or hepatic enzyme tests are ≥2.5 times normal limit. Significant cardiovascular event ≤ 6 months prior to screening visit; or stated history of congestive heart failure. Untreated hypo- or hyper-thyroidism, or other endocrinopathies associated with excessive androgen secretion. Refractory anemia with hemoglobin value <11.0 g/dl. Chronic, contagious, infectious disease, such as active tuberculosis, hepatitis B or C, or HIV. Current infection (requiring prescription antimicrobial or antiviral medication, or hospitalization), or has received corticosteroid treatment (with the exception of inhaled or topical steroids) in the last 3 months. Currently being prescribed pain/anti-inflammatory medication and/or is regularly consuming over the counter pain/anti-inflammatory medication for chronic, or persistent, pain, including but not limited to arthritic conditions, fibromyalgia, and continuous localized pain. History of allergy to any of the ingredients in the study products. Deleted Obstruction of the gastrointestinal tract precluding ingestion of the study product, inflammatory bowel disease, short bowel syndrome or other severe forms of gastrointestinal disease. Stated uncontrolled severe diarrhea, nausea or vomiting. Amputee. Actively pursuing weight loss or gain. Cannot refrain from taking medications/dietary supplements (all forms)/substances that could modulate metabolism or body weight. Cannot refrain from taking long chain n-3 polyunsaturated fatty acids (PUFA) (eicosapentaenoic acid (EPA) ± docosahexaenoic acid (DHA) ± α-linolenic acid (ALA)), or vitamin D, at levels that are significantly higher than the established Acceptable Macronutrient Distribution Range (AMDR), or recommended by the American Heart Association (500 mg/d total EPA+DHA), during the study. Cannot refrain from smoking or discontinue the use of nicotine (all forms including patches) or tobacco during the study. One or more metal implants. Currently diagnosis or a history of severe dementia or delirium, eating disorder, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance. Cannot abstain from alcohol use during the study.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 79 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control ONS<br>ONS without AN777 | Other: ONS without AN777<br>* 2 servings a day<br>* Other names: Commercially available ONS;|
| Experimental: Investigational ONS<br>ONS containing AN777 | Other: ONS containing AN777<br>* 2 servings a day<br>* Other names: Investigational ONS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total lean body mass | Change from baseline | Baseline to Study Day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hand-grip strength | Change from baseline | Baseline, Study Day 10, Study Week 6 and 12 | 
| Short Physical Performance Battery (SPPB) | Change from baseline | Baseline, Study Day 10, Study Week 6 and 12 | 
| Isokinetic leg strength | Change from baseline | Baseline, Study Day 10 and Study Week 12 | 
| Body Mass Index (BMI) | Calculated BMI = weight/height2 (kg/m2). | Screening Visits 1 and 3; Baseline; Study Days 2, 4, 6, 8 and 10; Study Weeks 3, 6, 9 and 12 | 
| Lower extremity lean mass | Measured by DXA; Change from baseline | Baseline, Study Day 10, Study Weeks 6 and 12 |