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

Completed · Not applicable · Has a placebo group

Conditions studied: Sarcopenia

In brief

Several trials have found that nutritional supplementation can elicit an increased rate of skeletal muscle protein synthesis following a single bout of exercise in both young and older individuals. However, there have been no studies that have investigated if nutritional supplementation and exercise can cause a sustained increase in physical functioning and fat free mass, particularly in older adults with functional limitations. This study will compare the effects of a nutritional supplement versus a placebo on exercise training induced changes in physical functioning older adults who are at risk for mobility disability.

Key facts

Study ID

NCT01542892

Run by

Tufts University

People needed

150

Starts

2011-10-01

Expected to finish

2014-08-01

Last updated by the study team

2014-11-18

Who can join

Age: 70 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• • 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.

Where it is running

• Jean Mayer Human Nutrition Research Center on Aging at Tufts University — Boston, Massachusetts, United States
• Uppsala University — Uppsala, Sweden

Full record on ClinicalTrials.gov

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