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

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.