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

Lookup NU author(s): Dr Kirsten BrandtORCiD, Emeritus Professor Chris SealORCiD



This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


© 2020, The Author(s). : 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.

Publication metadata

Author(s): Bauer JM, Mikusova L, Verlaan S, Bautmans I, Brandt K, Donini LM, Maggio M, Mets T, Wijers SLJ, Garthoff JA, Luiking Y, Sieber C, Cederholm T, on behalf of the PROVIDE Consortium

Publication type: Article

Publication status: Published

Journal: Aging Clinical and Experimental Research

Year: 2020

Volume: 32

Pages: 1501-1541

Online publication date: 12/03/2020

Acceptance date: 17/02/2020

Date deposited: 02/04/2020

ISSN (print): 1594-0667

ISSN (electronic): 1720-8319

Publisher: Springer


DOI: 10.1007/s40520-020-01519-x

PubMed id: 32162241


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