title: Effects of a vitamin D and leucine-enriched whey protein nutritional supplement on measures of sarcopenia in older adults, the PROVIDE study: a randomized, double-blind, placebo-controlled trial.
abstract: BACKGROUND
  Age-related losses of muscle mass, strength, and function (sarcopenia) pose significant threats to physical performance, independence, and quality of life. Nutritional supplementation could positively influence aspects of sarcopenia and thereby prevent mobility disability.
  
  
  OBJECTIVE
  To test the hypothesis that a specific oral nutritional supplement can result in improvements in measures of sarcopenia.
  
  
  METHODS
  A multicenter, randomized, controlled, double-blind, 2 parallel-group trial among 380 sarcopenic primarily independent-living older adults with Short Physical Performance Battery (SPPB; 0-12) scores between 4 and 9, and a low skeletal muscle mass index. The active group (n = 184) received a vitamin D and leucine-enriched whey protein nutritional supplement to consume twice daily for 13 weeks. The control group (n = 196) received an iso-caloric control product to consume twice daily for 13 weeks. Primary outcomes of handgrip strength and SPPB score, and secondary outcomes of chair-stand test, gait speed, balance score, and appendicular muscle mass (by DXA) were measured at baseline, week 7, and week 13 of the intervention.
  
  
  RESULTS
  Handgrip strength and SPPB improved in both groups without significant between-group differences. The active group improved more in the chair-stand test compared with the control group, between-group effect (95% confidence interval): -1.01 seconds (-1.77 to -0.19), P = .018. The active group gained more appendicular muscle mass than the control group, between-group effect: 0.17 kg (0.004-0.338), P = .045.
  
  
  CONCLUSIONS
  This 13-week intervention of a vitamin D and leucine-enriched whey protein oral nutritional supplement resulted in improvements in muscle mass and lower-extremity function among sarcopenic older adults. This study shows proof-of-principle that specific nutritional supplementation alone might benefit geriatric patients, especially relevant for those who are unable to exercise. These results warrant further investigations into the role of a specific nutritional supplement as part of a multimodal approach to prevent adverse outcomes among older adults at risk for disability.
authors.affiliation: Department of Geriatric Medicine, Carl von Ossietzky University, Oldenburg, Germany. Electronic address: bauer.juergen@klinikum-oldenburg.de.
authors.forename: Jürgen M
authors.initials: JM
authors.lastname: Bauer
authors.affiliation: Nutricia Research, Nutricia Advanced Medical Nutrition, Utrecht, The Netherlands; Department of Internal Medicine, Section of Gerontology and Geriatrics, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: Sjors
authors.initials: S
authors.lastname: Verlaan
authors.affiliation: Frailty in Ageing research group (FRIA), Vrije Universiteit Brussel (VUB), Brussels, Belgium.
authors.forename: Ivan
authors.initials: I
authors.lastname: Bautmans
authors.affiliation: Human Nutrition Research Centre, School of Agriculture, Food and Rural Development, Newcastle University Institute for Ageing, Newcastle University, Agriculture Building, Kings Road, Newcastle upon Tyne, United Kingdom.
authors.forename: Kirsten
authors.initials: K
authors.lastname: Brandt
authors.affiliation: Department of Experimental Medicine, Section of Medical Pathophysiology, Endocrinology and Human Nutrition, "Sapienza" University of Rome, Rome, Italy.
authors.forename: Lorenzo M
authors.initials: LM
authors.lastname: Donini
authors.affiliation: Department of Clinical and Experimental Medicine, Section of Geriatrics, Movement Disorders and Prevention of Disability Unit Food Sciences Unit and Endocrinology of Aging Unit, University of Parma, University Hospital, Parma, Italy.
authors.forename: Marcello
authors.initials: M
authors.lastname: Maggio
authors.affiliation: Ageing and Health, Ninewells Hospital and Medical School, University of Dundee, Ninewells Hospital, Dundee, United Kingdom.
authors.forename: Marion E T
authors.initials: ME
authors.lastname: McMurdo
authors.affiliation: Frailty in Ageing research group (FRIA), Vrije Universiteit Brussel (VUB), Brussels, Belgium.
authors.forename: Tony
authors.initials: T
authors.lastname: Mets
authors.affiliation: Human Nutrition Research Centre, School of Agriculture, Food and Rural Development, Newcastle University Institute for Ageing, Newcastle University, Agriculture Building, Kings Road, Newcastle upon Tyne, United Kingdom.
authors.forename: Chris
authors.initials: C
authors.lastname: Seal
authors.affiliation: Nutricia Research, Nutricia Advanced Medical Nutrition, Utrecht, The Netherlands.
authors.forename: Sander L
authors.initials: SL
authors.lastname: Wijers
authors.affiliation: Department of Clinical and Experimental Medicine, Section of Geriatrics, Movement Disorders and Prevention of Disability Unit Food Sciences Unit and Endocrinology of Aging Unit, University of Parma, University Hospital, Parma, Italy.
authors.forename: Gian Paolo
authors.initials: GP
authors.lastname: Ceda
authors.affiliation: Institute for Sport and Health, University College Dublin, Belfield, Dublin, Ireland.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: De Vito
authors.affiliation: Femicare, Clinical Research for Women, Tienen, Belgium.
authors.forename: Gilbert
authors.initials: G
authors.lastname: Donders
authors.affiliation: Medizinische Klinik und Poliklinik IV, Schwerpunkt Akutgeriatrie, Klinikum der Universität München (LMU), Munich, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Drey
authors.affiliation: School of Sport, Exercise and Rehabilitation Sciences and Centre for Musculoskeletal Ageing Research, University of Birmingham, Edgbaston, Birmingham, United Kingdom.
authors.forename: Carolyn
authors.initials: C
authors.lastname: Greig
authors.affiliation: Department of Public Health and Caring Sciences/Clinical Nutrition and Metabolism, Department of Geriatric Medicine, Uppsala University Hospital, Uppsala, Sweden.
authors.forename: Ulf
authors.initials: U
authors.lastname: Holmbäck
authors.affiliation: Faculty of Medicine, MRC ARUK Centre for Musculoskeletal Ageing Research, Royal Derby Hospital, University of Nottingham, Derby, United Kingdom.
authors.forename: Marco
authors.initials: M
authors.lastname: Narici
authors.affiliation: School of Healthcare Science, Manchester Metropolitan University, All Saints, Manchester, United Kingdom.
authors.forename: Jamie
authors.initials: J
authors.lastname: McPhee
authors.affiliation: Department of Experimental Medicine, Section of Medical Pathophysiology, Endocrinology and Human Nutrition, "Sapienza" University of Rome, Rome, Italy.
authors.forename: Eleonora
authors.initials: E
authors.lastname: Poggiogalle
authors.affiliation: Department of Medicine for Older Persons, Mater Misericordiae University Hospital and University College Dublin, Belfield, Dublin, Ireland.
authors.forename: Dermot
authors.initials: D
authors.lastname: Power
authors.affiliation: Frailty in Ageing research group (FRIA), Vrije Universiteit Brussel (VUB), Brussels, Belgium.
authors.forename: Aldo
authors.initials: A
authors.lastname: Scafoglieri
authors.affiliation: St-Marien Hospital Clinic for Geriatrics, Cologne, Germany.
authors.forename: Ralf
authors.initials: R
authors.lastname: Schultz
authors.affiliation: Institute for Biomedicine on Ageing, Friedrich-Alexander-University Erlangen-Nürnberg, Nürnberg, Germany.
authors.forename: Cornel C
authors.initials: CC
authors.lastname: Sieber
authors.affiliation: Department of Public Health and Caring Sciences/Clinical Nutrition and Metabolism, Department of Geriatric Medicine, Uppsala University Hospital, Uppsala, Sweden.
authors.forename: Tommy
authors.initials: T
authors.lastname: Cederholm
mesh_terms: D000368:Aged; D019587:Dietary Supplements; D004311:Double-Blind Method; D005060:Europe; D005260:Female; D015577:Geriatric Assessment; D018737:Hand Strength; D006801:Humans; D007930:Leucine / Q000627:therapeutic use*; D008297:Male; D051346:Mobility Limitation; D011502:Protein-Energy Malnutrition / Q000188:drug therapy* / Q000503:physiopathology; D055948:Sarcopenia / Q000188:drug therapy* / Q000503:physiopathology; D016896:Treatment Outcome; D014807:Vitamin D / Q000627:therapeutic use*; D000067816:Whey Proteins / Q000627:therapeutic use*
chemical_list: D000067816:Whey Proteins; D014807:Vitamin D; D007930:Leucine
keywords: Sarcopenia; lower extremity function; muscle mass; nutritional supplementation; protein