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

Bauer JM, Mikušová L, Verlaan S, Bautmans I, Brandt K, Donini LM, Maggio M, Mets T, Wijers SL, Garthoff JA, Luiking Y, Sieber C, Cederholm T, Bauer JM, McMurdo ME, Seal C, 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 (2020)

Publication Type: Journal article

Publication year: 2020

Journal

Aging Clinical and Experimental Research Editrice Kurtis

DOI: 10.1007/s40520-020-01519-x

Abstract

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.

Authors with CRIS profile

Cornel Sieber Lehrstuhl für Innere Medizin (Geriatrie)

Involved external institutions

Università degli studi "La Sapienza" IT Italy (IT) Newcastle University GB United Kingdom (GB) Vrije Universiteit Brussel (VUB) BE Belgium (BE) Danone Nutricia Research NL Netherlands (NL) Amsterdam University Medical Centers (Amsterdam UMC) / Amsterdam Universitair Medische Centra NL Netherlands (NL) Uppsala University Hospital / Akademiska sjukhuset SE Sweden (SE) University of Parma / Università degli Studi di Parma IT Italy (IT) Ruprecht-Karls-Universität Heidelberg DE Germany (DE)

How to cite

APA:

Bauer, J.M., Mikušová, L., Verlaan, S., Bautmans, I., Brandt, K., Donini, L.M.,... Schultz, R. (2020). Safety and tolerability of 6-month supplementation with a vitamin D, calcium and leucine-enriched whey protein medical nutrition drink in sarcopenic older adults. Aging Clinical and Experimental Research. https://doi.org/10.1007/s40520-020-01519-x

MLA:

Bauer, Jürgen M., et al. "Safety and tolerability of 6-month supplementation with a vitamin D, calcium and leucine-enriched whey protein medical nutrition drink in sarcopenic older adults." Aging Clinical and Experimental Research (2020).

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