|Kirn, Dylan - Jean Mayer Human Nutrition Research Center On Aging At Tufts University|
|Koochek, Afsaneh - Uppsala University|
|Reid, Kieran - Jean Mayer Human Nutrition Research Center On Aging At Tufts University|
|Von Berens, Asa - Uppsala University|
|Travison, Thomas - Hebrew Senior Life|
|Folta, Sara - Tufts University|
|Sacheck, Jennifer - Tufts University|
|Nelson, Miriam - Tufts University|
|Liu, Christine - Jean Mayer Human Nutrition Research Center On Aging At Tufts University|
|Phillips, Edward - Jean Mayer Human Nutrition Research Center On Aging At Tufts University|
|Aberg, Anna - Uppsala University|
|Nydahl, Margaretha - Uppsala University|
|Gustafsson, Thomas - Karolinska University Hospital|
|Cederholm, Tommy - Uppsala University|
|Fielding, Roger - Jean Mayer Human Nutrition Research Center On Aging At Tufts University|
Submitted to: Contemporary Clinical Trials
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 6/1/2015
Publication Date: 6/2/2015
Citation: Kirn, D., Koochek, A., Reid, K.F., Von Berens, A., Travison, T.G., Folta, S., Sacheck, J., Nelson, M., Liu, C., Phillips, E., Aberg, A.C., Nydahl, M., Gustafsson, T., Cederholm, T., Fielding, R.A. 2015. The vitality, independence, and vigor in the elderly 2 study (VIVE2): design and methods. Contemporary Clinical Trials. 43:164-171. https://doi.org/10.1016/j.cct.2015.06.001.
Interpretive Summary: Mobility limitations, such as the inability to rise from a chair or ascend a flight of stairs, affect many older adults. As such, there is a substantial need for interventions to address the inevitable increase in mobility limitations among this population. Inadequate physical activity and low protein intake are two factors that contribute to the decline in muscle mass and function associated with aging (sarcopenia.) To date, no studies have been conducted to determine whether synergistic effects of exercise and nutrition can result in sustained increases in physical functioning and fat free mass. Such investigations would be of particular relevance to older adults with demonstrated functional limitations, who are at disproportionate risk for mobility disability. The randomized clinical trial described here will compare the effects of an intervention with an experimental liquid oral nutritional supplement providing 150 kcal, high amounts of whey protein (20g), and high amounts of vitamin D (800 IU) in a small volume to a low calorie placebo drink on exercise training-induced changes in physical functioning in older adults with demonstrated mobility limitations and vitamin D insufficiency who are considered at risk for mobility disability. The primary outcome for this study will be the change in 400 M walk time at baseline and follow up between groups. Secondary outcomes include body composition, muscle cross-sectional area, quality of life, depression, lower-extremity strength and power, stair climb time, and the short physical performance battery.
Technical Abstract: Background: Nutritional supplementation may potentiate the increase in skeletal muscle protein synthesis following exercise in healthy older individuals. Whether exercise and nutrition act synergistically to produce sustained changes in physical functioning and body composition has not been well studied, particularly in mobility-limited older adults. Methods: The VIVE2 study was a multi-center, randomized controlled trial, conducted in the United States and Sweden. This study was designed to compare the effects of a 6-month intervention with a once daily, experimental, 4 fl. oz. liquid nutritional supplement providing 150 kcal, whey protein (20 g), and vitamin D (800 IU) (Nestle Health Science, Vevey, Switzerland), to a low calorie placebo drink (30 kcal, non-nutritive; identical format) when combined with group-based exercise in 150 community-dwelling, mobility-limited older adults. All participants participated in a structured exercise program (3 sessions/week for 6 months), which included aerobic, strength, flexibility, and balance exercises. Results: The primary outcome was 6-month change in 400 m walk performance (m/s) between supplement and placebo groups. Secondary outcomes included 6 month change in: body composition, muscle cross-sectional area, leg strength, grip strength, stair climb time, quality of life, physical performance, mood/depressive symptoms and nutritional status. These outcomes were selected based on their applicability to the health and wellbeing of older adults. Conclusions: The results of this study will further define the role of nutritional supplementation on physical functioning and restoration of skeletal muscle mass in older adults. Additionally, these results will help refine the current physical activity and nutritional recommendations for mobility-limited older adults.