Safety and tolerability of 6-month supplementation with a vitamin D, calcium and leucine-enriched whey protein medical nutrition drink in sarcopenic older adults

  1. Mikušová, Lucia
  2. Garthoff, Jossie A.
  3. Luiking, Yvette
  4. Bauer, Jürgen M.
  5. Verlaan, Sjors
  6. Bautmans, Ivan
  7. Brandt, Kirsten
  8. Donini, Lorenzo M.
  9. Maggio, Marcello
  10. McMurdo, Marion E. T.
  11. Mets, Tony
  12. Seal, Chris
  13. Wijers, Sander L. J.
  14. Ceda, Gian Paolo
  15. De Vito, Giuseppe
  16. Donders, Gilbert
  17. Drey, Michael
  18. Greig, Carolyn
  19. Holmbäck, Ulf
  20. Narici, Marco
  21. McPhee, Jamie
  22. Poggiogalle, Eleonora
  23. Power, Dermot
  24. Scafoglieri, Aldo
  25. Schultz, Ralf
  26. Sieber, Cornel
  27. Cederholm, Tommy

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1000 Titel
  • Safety and tolerability of 6-month supplementation with a vitamin D, calcium and leucine-enriched whey protein medical nutrition drink in sarcopenic older adults
1000 Autor/in
  1. Mikušová, Lucia |
  2. Garthoff, Jossie A. |
  3. Luiking, Yvette |
  4. Bauer, Jürgen M. |
  5. Verlaan, Sjors |
  6. Bautmans, Ivan |
  7. Brandt, Kirsten |
  8. Donini, Lorenzo M. |
  9. Maggio, Marcello |
  10. McMurdo, Marion E. T. |
  11. Mets, Tony |
  12. Seal, Chris |
  13. Wijers, Sander L. J. |
  14. Ceda, Gian Paolo |
  15. De Vito, Giuseppe |
  16. Donders, Gilbert |
  17. Drey, Michael |
  18. Greig, Carolyn |
  19. Holmbäck, Ulf |
  20. Narici, Marco |
  21. McPhee, Jamie |
  22. Poggiogalle, Eleonora |
  23. Power, Dermot |
  24. Scafoglieri, Aldo |
  25. Schultz, Ralf |
  26. Sieber, Cornel |
  27. Cederholm, Tommy |
1000 Erscheinungsjahr 2020
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2020-03-12
1000 Erschienen in
1000 Quellenangabe
  • 32(8):1501-1514
1000 Copyrightjahr
  • 2020
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.1007/s40520-020-01519-x |
  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7452877/ |
1000 Publikationsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • Aims!#!Safety and tolerability of prolonged supplementation with a vitamin D, calcium and leucine-enriched whey protein medical nutrition drink (WP-MND) was evaluated in sarcopenic older adults.!##!Methods!#!A 13-week double-blinded, randomized, isocaloric placebo-controlled trial (PROVIDE study; n = 380) was extended with a voluntary 13-week open-label extension (OLE). OLE participants were randomized to receive daily 1 or 2 servings of WP-MND (21 g protein, 3 g leucine, 10 µg vitD and 500 mg calcium per serving). Gastro-intestinal tolerability, kidney function and serum levels of calcidiol, parathyroid hormone (PTH) and calcium were evaluated at week 0, 13 and 26.!##!Results and discussion!#!In response to the high daily protein intake (median1.5; IQR: 1.3, 1.7 g/kg BW/day), the estimated glomerular filtration rate (eGFR) increased in the test group during the RCT (p = 0.013). The same trend was observed for those participants with moderate chronic kidney disease. During OLE no eGFR change was observed in any of the groups. Serum calcidiol and calcium reached a plateau after 13-week WP-MND supplementation. As expected, PTH significantly changed in the opposite direction, decreasing during RCT in the test group (T vs C: p < 0.001) and during OLE in former control groups. During RCT, 20/366 participants with normal baseline calcidiol reached levels ≥ 100 nmol/L (T: n = 18; C: n = 2) and 6 developed albumin-corrected calcium levels > 2.55 mmol/L (T: n = 3; C: n = 3), without associated adverse events.!##!Conclusion!#!A 6 months intervention with up to 2 servings of WP-MND did neither result in kidney function deterioration nor symptoms of vitamin D or calcium toxicity. The product was overall well tolerated.
1000 Sacherschließung
lokal Whey Proteins/adverse effects [MeSH]
lokal Double-Blind Method [MeSH]
lokal Female [MeSH]
lokal Nutrition
lokal Aged [MeSH]
lokal Humans [MeSH]
lokal Sarcopenia/diet therapy [MeSH]
lokal Whey protein
lokal Safety
lokal Vitamin D [MeSH]
lokal Original Article
lokal Male [MeSH]
lokal Dietary Supplements [MeSH]
lokal Leucine/adverse effects [MeSH]
lokal Sarcopenia
lokal Vitamin D
lokal Calcium [MeSH]
lokal Tolerability
1000 Liste der Beteiligten
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1000 Erstellt am 2023-11-18T16:05:31.673+0100
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