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.
Bibliographical noteFunding Information:
Jürgen Bauer is a scientific advisor and has received research grants and speakers honorarium from Nutricia and Nestlé. Lucia Mikušová, Sander Wijers and Yvette Luiking are employed by Danone Nutricia Research, Sjors Verlaan was an employee in the past and Jossie Garthoff works for Danone Food Safety Center. Tommy Cederholm has given remunerated lectures and has received unconditional research grants from Nutricia and Nestlé. Kirsten Brandt received a research grant from Nutricia Research during the conduct of the study. Ivan Bautmans, Tony Mets, Lorenzo M Donini, Marcello Maggio and Cornel Sieber declare that they have no conflict of interest.
Open Access funding provided by Projekt DEAL. We thank all participants for their participation in RCT and the voluntary open-label extension study period dedicating their time and energy. We are grateful to the research staff members at each study site for their commitment to achieving the aims of this study. We are thankful to the PROVIDE study group* for their professional oversight and guidance. We are thankful to Gerdien Ligthart-Melis, PhD (GCLM-Nutriscience) for drafting this manuscript and Laure Verstraeten for creating the tables on GI tolerability and vital signs, as well as a quality check of all the data reported in the paper. *PROVIDE study group members: J?rgen M Bauer, Sjors Verlaan, Ivan Bautmans, Kirsten Brandt, Lorenzo M Donini, Marcello Maggio, Marion ET McMurdo, Tony Mets, Chris Seal, Sander LJ Wijers, Gian Paolo Ceda, Giuseppe De Vito, Gilbert Donders, Michael Drey, Carolyn Greig, Ulf Holmb?ck, Marco Narici, Jamie McPhee, Eleonora Poggiogalle, Dermot Power, Aldo Scafoglieri, Ralf Schultz, Cornel Sieber, Tommy Cederholm.
This study was financially supported and study products were provided by Danone Nutricia Research, Nutricia Advanced Medical Nutrition. The funding source was involved at all stages of the study. Acknowledgements
© 2020, The Author(s).
Copyright 2020 Elsevier B.V., All rights reserved.
- Vitamin D;
- Whey protein