Efficacy of Nutritional Supplementation on Physical-activity Mediated Changes in Physical Functioning Older Adults at Risk for Mobility Disability (The VIVE2 Study)

Inclusion Criteria:

1. Male & Female ≥ 70 yrs
2. Community dwelling
3. Short Physical Performance Battery ≤ 9
4. Willingness to be randomized and come to the laboratory for 6 months
5. Body Mass Index < 35
6. Mini-Mental State Examination >=24
7. Serum 25 (OH) D (22.5 -50 nmol/l)
8. Having obtained his/her informed consent
9. Able to complete 400 M walk within 15 minutes

Exclusion Criteria:

• • Acute or terminal illness; terminal illness with life expectancy less than 12 months, as determined by a physician

  • Current regular use (> 1 per week) of high protein oral nutritional supplements (eg: Boost, Exceed etc…)
  • Current use of Vitamin D supplements, >800 IU/day
  • Myocardial infarction in previous 6 months, symptomatic coronary artery disease, or congestive heart failure.
  • Upper or lower extremity fracture in previous 6 months.
  • Hemoglobin < 10 g/dL, Estimated GFR < 30 mL/min/1.73 m2
  • Uncontrolled hypertension (>150/90 mm Hg).
  • Neuromuscular diseases and drugs which affect neuromuscular function; severe progressive, degenerative neurologic disease
  • Hormone replacement therapy
  • Insulin-dependent diabetes mellitus
  • Milk protein allergy
  • Major surgery in the past 6 months (requiring general anesthesia)
  • Other significant co-morbid disease that would impair ability to participate in the exercise-based intervention, e.g. renal failure on hemodialysis, severe psychiatric disorder (e.g. bipolar, schizophrenia)
  • Excessive alcohol use (>14 drinks per wk)
  • Participation in moderate intensity physical activity > 20 minutes/week
  • Inability to communicate due to severe, uncorrectable hearing loss or speech disorder
  • Severe visual impairment (if it precludes completion of assessments and/or intervention)
  • Severe rheumatologic or orthopedic diseases, e.g., awaiting joint replacement, active inflammatory disease; wheelchair bound
  • Cancer requiring treatment in the past three years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis (e.g., Stage 1 cervical cancer)
  • Severe pulmonary disease, requiring either steroid pills or injections or the use of supplemental oxygen
  • Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina
  • Patient who cannot be expected to comply with treatment, as decided by the Principal Investigator and study physician.
  • Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the clinical site Principal Investigator and/or study physician.