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The Vitality, Independence, and Vigor in the Elderly 2 Study (VIVE2): Design and methods.

Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, MA, United States. Electronic address: Dylan.kirn@tufts.edu. Clinical Nutrition and Metabolism, Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden. Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, MA, United States. Institute for Aging Research, Hebrew SeniorLife, Boston, MA, United States; Harvard Medical School, Boston, MA, United States; Division of Gerontology, Beth Israel Deaconess Medical Center, Boston, MA, United States. Friedman School of Nutrition Science and Policy, Tufts University, Boston, MA, United States. Friedman School of Nutrition Science and Policy, Tufts University, Boston, MA, United States; Jonathan M. Tisch College of Citizenship and Public Service, Tufts University, Medford, MA, United States. Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, MA, United States; Section of Geriatrics, Boston University School of Medicine, Boston, MA, United States. Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, MA, United States; Harvard Medical School, Boston, MA, United States; Spaulding Rehabilitation Hospital, Boston, MA, United States. Geriatrics, Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden; School of Education, Health and Society, Dalarna University, Sweden. Department of Food, Nutrition and Dietetics, Uppsala University, Uppsala, Sweden. Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.

Contemporary clinical trials. 2015;:164-71
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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) (Nestlé 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 well-being 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.

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