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

Inclusion Criteria:

- Subject is male or female and is greater than or equal to 60 to less than or equal to
79 years of age.

- Subject has Body Mass Index (BMI) greater than or equal to 20 but less than or equal
to 35 kg/m2.

- Subject is ambulatory with a Short Physical Performance Battery (SPPB) score of
greater than or equal to 9 (fully functional with no mobility limitations).

- Subject's triacylglyceride (TAG) level is less than or equal to 250 mg/dl and LDL
cholesterol is less than or equal to 150 mg/dl.

- Subject agrees to comply with the various activity levels required for this study.

- Subject has an ankle brachial index within the normal range, between 1 and 1.4, as
defined by the American Heart Association Task Force on Practice Guidelines.

- Subject has voluntarily signed and dated an informed consent form (ICF), approved by
an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), and provided
Health Insurance Portability and Accountability Act (HIPAA) (or other applicable
privacy regulation) authorization prior to any participation in the study.

- Subject has a physical activity score that is within the 2008 Guidelines for
Americans (7.5 to 17.7 metabolic equivalent of task (MET) hours) or above, as
assessed by the CHAMPS Physical Activity Questionnaire for Older Adults

- Subject has normal-good handgrip strength (greater than or equal to 29 kg for males
and greater than or equal to 18.5 kg for females).

Exclusion Criteria:

- Subject has either Type I or Type II Diabetes Mellitus.

- Subject has an abnormal (greater than 110 but less than126 mg/dl) fasting blood
glucose level.

- Subject has undergone 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 during the entire study.

- Subject has a history of pressure ulcers

- Subject has a stated history of Deep Vein Thrombosis (DVT), recent (within last 3
months) pulmonary embolism, carotid atherosclerosis, transient ischemic attack (TIA),
or a stated hypercoaguable condition, or other stated clotting or bleeding disorder,
or is currently prescribed blood thinners, or has a positive D-dimer test with or
without a positive lower extremity ultrasound at screening.

- Subject has varicose veins that in the opinion of the study physician would result in
significant discomfort while wearing ThromboEmbolic Disease (TED) hose and/or
Sequential Compression Device (SCD).

- Subject has stated autoimmune disease or active malignant disease, except basal or
squamous cell skin carcinoma or carcinoma in situ of the uterine cervix.

- Subject's estimated glomerular filtration rate is less than 60ml/min/1.73m2.

- Subject has current significantly impaired liver function in the opinion of the study
principal investigator /physician (mild unsymptomatic fatty liver is acceptable), or
hepatic enzyme tests are greater than or equal to 2.5 times normal limit.

- Subject has a stated history of a significant cardiovascular event (e.g. myocardial
infarction, arrhythmia, or stroke) less than or equal to 6 months prior to screening
visit; or stated history of congestive heart failure.

- Subject has hypo- or hyper-thyroidism, or other endocrinopathies associated with
excessive androgen secretion (including Addison's Disease and Cushing's
Disease/Syndrome).

- Subject has refractory anemia with hemoglobin value less than 11.0 g/dl.

- Subject has a chronic, contagious, infectious disease, such as active tuberculosis,
hepatitis B or C, or HIV.

- Subject has 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 prior to screening
visit.

- Subject is currently being prescribed (by primary care physician or other health
professional) pain/anti-inflammatory medication, such as specific Cox-2 inhibitors,
and/or is consuming over the counter pain/anti-inflammatory medication for chronic
pain.

- Subject has a history of allergy to any of the ingredients in the study products.

- Subject is currently taking statins and has a stated history of statin induced
myopathy.

- Subject has an obstruction of the gastrointestinal tract precluding ingestion of the
study product, inflammatory bowel disease, short bowel syndrome or other severe forms
of gastrointestinal disease such as gastroesophageal reflux disease, gastroparesis,
peptic ulcer disease, celiac disease, intestinal dysmotility, diverticulitis, or
ischemic colitis.

- Subject has stated uncontrolled severe diarrhea, nausea or vomiting.

- Subject is an amputee.

- Subject is actively pursuing weight loss or gain.

- Subject cannot refrain from taking medications/dietary supplements (all
forms)/substances that could modulate metabolism or body weight in the opinion of the
PI/physician, starting at screening and over the entire course of the study. These
include progestational agents, steroids, prescription strength anti-inflammatories,
growth hormone, dronabinol, marijuana, calcium-beta-hydroxyl-beta-methylbutyrate
(CaHMB) or other forms of HMB, free and/or branched chain amino acid supplements,
dietary supplements to aid weight loss, including thermogenic supplements. Exceptions
are made for multi-vitamin/mineral supplements not exceeding the Daily Reference
Intakes, inhaled steroids for asthma, and short term (less than 2 weeks) use of
topical, optical or oral steroids.

- Subject 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
Recommended Daily Intakes (RDI) or the Acceptable Macronutrient Distribution Range
(AMDR), starting at screening and for the entire duration of the study.

- Subject cannot refrain from smoking or discontinue the use of nicotine (all forms
including patches) or tobacco during the pre-bed rest period and 10 day bed rest
period.

- Subject is deemed unsuitable for study based upon study physician assessment.

- Subject is taking part in a non-Abbott Nutrition approved clinical trial.

- Subject has one or more metal implants that in the opinion of the study physician/PI
would have a significant impact on the dual energy x-ray absorptiometry (DXA)
analysis.

- Subject is currently diagnosed with, or has 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 with study protocol procedures in the opinion of the
principal investigator or study physician.

- Subject cannot abstain from alcohol for the pre-bed rest and bed rest portions of the
study.