Safety and tolerability of 6-month supplementation with a vitamin D, calcium and leucine-enriched whey protein medical n
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ORIGINAL ARTICLE
Safety and tolerability of 6‑month supplementation with a vitamin D, calcium and leucine‑enriched whey protein medical nutrition drink in sarcopenic older adults Jürgen M. Bauer1 · Lucia Mikušová2 · Sjors Verlaan3 · Ivan Bautmans4 · Kirsten Brandt5 · Lorenzo M. Donini6 · Marcello Maggio7 · Tony Mets4 · Sander L. J. Wijers2 · Jossie A. Garthoff8 · Yvette Luiking2 · Cornel Sieber9 · Tommy Cederholm10 on behalf of the PROVIDE Consortium Received: 22 November 2019 / Accepted: 17 February 2020 © The Author(s) 2020
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 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. Keywords Nutrition · Safety · Tolerability · Sarcopenia · Whey protein · Vitamin D
* Jürgen M. Bauer Juergen.Bauer@bethanien‑heidelberg.de 1
2
Center for Geriatric Medicine, University Heidelberg, Agaplesion Bethanien Krankenhaus Heidelberg, Heidelberg, Germany Danone Nutricia Research, Nutricia Advanced Medical Nutrition, Utrecht, The Netherlands
3
Department of Internal Medicine, Section of Gerontology and Geriatrics, VU, Amsterdam University Medical Center, Amsterdam, The Netherlands
4
Frailty in Ageing Research Group (FRIA), Vrije Universiteit Brussel (VUB), Brussels, Belgium
5
Human Nutrition Research Centre, School of Agriculture, Food and Rural Development, Newcastle University Institute for Ageing, Newcastle University, Newcastle upon Tyne, UK
6
Department of Experimental Medicine, Section of Medical Pathophysiology, Endocrinology and Human Nutrition, “Sapienza” University of Rome, Rome, Italy
7
Department of Clinical and Experimental Medicine, Section of Geriat
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