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Ensayo controlado aleatorizado2015

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

Bauer JM, Verlaan S, Bautmans I, Brandt K, Donini LM, Maggio M, McMurdo ME, Mets T, Seal C, Wijers SL, Ceda GP, De Vito G, Donders G, Drey M, Greig C, Holmbäck U, Narici M, McPhee J, Poggiogalle E, Power D, Scafoglieri A, Schultz R, Sieber CC, Cederholm T

Journal of the American Medical Directors Association · 485 citas

Cómo se estudió

Diseño
Ensayo controlado aleatorizado (indexado por PubMed)
Estudiado en
Personas
Resultado principal
Marcadores de salud y funcionamiento
Consumo medido con
No se indica

Quién lo pagó

Financiación
Financiación independiente
Universidad u hospital
Universiteit Utrecht
Gobierno
Medical Research Council
Universidad u hospital
Wageningen University and Research
Subvenciones
Medical Research Council (MR/K00414X/1)

Según 3 financiadores declarados.

Publicación

Publicado
2015-07-11 · J Am Med Dir Assoc · vol. 16 · número 9 · págs. 740–747
Editorial
Elsevier BV
Citado
668 citas · más que el 100% de estudios similares · 44.3× el promedio de su campo
Impacto
Entre el 10 % más citado de su campo
Referencias
56 trabajos
Acceso
Acceso abierto (revista híbrida) · CC-BY-NC-ND
Áreas de investigación
Nutrition and Health in Aging · Muscle metabolism and nutrition · Muscle Physiology and Disorders
Palabras clave
sarcopenia, vitamin D, dietary supplementation, older adults, grip strength, Short Physical Performance Battery, appendicular skeletal muscle mass, chair stand test, walking speed, balance, skeletal muscle mass
MeSH
humans, protein-energy malnutrition, vitamin d, leucine, hand strength, treatment outcome, geriatric assessment, double-blind method, dietary supplements, aged, europe, female, male, mobility limitation, sarcopenia, whey proteins

24 autores

  • Jürgen Martin Bauer🇩🇪 · autor de correspondenciaCarl von Ossietzky Universität Oldenburg; Klinikum Oldenburg
  • Sjors Verlaan🇳🇱Nutricia Research (Netherlands); Amsterdam UMC Location Vrije Universiteit Amsterdam
  • Ivan Bautmans🇧🇪Vrije Universiteit Brussel
  • Kirsten Brandt🇬🇧Newcastle University
  • Lorenzo M. Donini🇮🇹Sapienza University of Rome
  • Marcello Giuseppe Maggio🇮🇹University of Parma; Ospedale di Parma
  • Marion E. T. McMurdo🇬🇧University of Dundee; Ninewells Hospital
  • Tony F. Mets🇧🇪Vrije Universiteit Brussel
  • Chris J. Seal🇬🇧Newcastle University
  • Sander L. J. Wijers🇳🇱Nutricia Research (Netherlands)
  • Gian Paolo Ceda🇮🇹University of Parma; Ospedale di Parma
  • Giuseppe DE VITO🇮🇪University College Dublin
  • Gilbert G.G. Donders
  • Michael Drey🇩🇪LMU Klinikum; Ludwig-Maximilians-Universität München
  • Carolyn Anne Greig🇬🇧University of Birmingham
  • Ulf C. Holmbäck🇸🇪Uppsala University Hospital
  • Marco Vincenzo Narici🇬🇧University of Nottingham; Royal Derby Hospital
  • Jamie Stewart McPhee🇬🇧Manchester Metropolitan University
  • Eleonora Poggiogalle🇮🇹Sapienza University of Rome
  • Dermot Power🇮🇪University College Dublin; Mater Misericordiae University Hospital
  • Aldo Scafoglieri🇧🇪Vrije Universiteit Brussel
  • Ralf Schultz
  • Cornel Christian Sieber🇩🇪Friedrich-Alexander-Universität Erlangen-Nürnberg
  • Tommy Cederholm🇸🇪Uppsala University Hospital

Resumen

El texto original del estudio, en el idioma en que se publicó.

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.

Design

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.

Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY-NC-ND).

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