title: The Vitality, Independence, and Vigor in the Elderly 2 Study (VIVE2): Design and methods.
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.
authors.affiliation: 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.
authors.forename: Dylan R
authors.initials: DR
authors.lastname: Kirn
authors.affiliation: Clinical Nutrition and Metabolism, Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.
authors.forename: Afsaneh
authors.initials: A
authors.lastname: Koochek
authors.affiliation: Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, MA, United States.
authors.forename: Kieran F
authors.initials: KF
authors.lastname: Reid
authors.affiliation: Clinical Nutrition and Metabolism, Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.
authors.forename: Åsa
authors.initials: Å
authors.lastname: von Berens
authors.affiliation: 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.
authors.forename: Thomas G
authors.initials: TG
authors.lastname: Travison
authors.affiliation: Friedman School of Nutrition Science and Policy, Tufts University, Boston, MA, United States.
authors.forename: Sara
authors.initials: S
authors.lastname: Folta
authors.affiliation: Friedman School of Nutrition Science and Policy, Tufts University, Boston, MA, United States.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Sacheck
authors.affiliation: 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.
authors.forename: Miriam
authors.initials: M
authors.lastname: Nelson
authors.affiliation: 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.
authors.forename: Christine
authors.initials: C
authors.lastname: Liu
authors.affiliation: 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.
authors.forename: Edward
authors.initials: E
authors.lastname: Phillips
authors.affiliation: Geriatrics, Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden; School of Education, Health and Society, Dalarna University, Sweden.
authors.forename: Anna Cristina
authors.initials: AC
authors.lastname: Åberg
authors.affiliation: Department of Food, Nutrition and Dietetics, Uppsala University, Uppsala, Sweden.
authors.forename: Margaretha
authors.initials: M
authors.lastname: Nydahl
authors.affiliation: Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Thomas
authors.initials: T
authors.lastname: Gustafsson
authors.affiliation: Clinical Nutrition and Metabolism, Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.
authors.forename: Tommy
authors.initials: T
authors.lastname: Cederholm
authors.affiliation: Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, MA, United States.
authors.forename: Roger A
authors.initials: RA
authors.lastname: Fielding
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001823:Body Composition / Q000502:physiology*; D015992:Body Mass Index; D004044:Dietary Proteins / Q000008:administration & dosage; D019587:Dietary Supplements; D015444:Exercise; D005260:Female; D006801:Humans; D008297:Male; D053580:Muscle Strength / Q000502:physiology*; D018482:Muscle, Skeletal / Q000502:physiology*; D004856:Postural Balance; D014807:Vitamin D / Q000008:administration & dosage; D016138:Walking
chemical_list: D004044:Dietary Proteins; D014807:Vitamin D
keywords: Mobility-limitations; Older adults; Physical activity; Protein; Supplementation; Vitamin D