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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. / PROVIDE Consortium; Bauer, Jürgen M.

In: Aging Clinical and Experimental Research, Vol. 32, No. 8, 01.08.2020, p. 1501-1514.

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PROVIDE Consortium ; Bauer, Jürgen M. / Safety and tolerability of 6-month supplementation with a vitamin D, calcium and leucine-enriched whey protein medical nutrition drink in sarcopenic older adults. In: Aging Clinical and Experimental Research. 2020 ; Vol. 32, No. 8. pp. 1501-1514.

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@article{3a849eb6786a464d81d60666cb31cb28,
title = "Safety and tolerability of 6-month supplementation with a vitamin D, calcium and leucine-enriched whey protein medical nutrition drink in sarcopenic older adults",
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.",
keywords = "Nutrition, Safety, Sarcopenia, Tolerability, Vitamin D;, Whey protein",
author = "{PROVIDE Consortium} and Bauer, {J{\"u}rgen M} and Lucia Mikušov{\'a} and Sjors Verlaan and Ivan Bautmans and Kirsten Brandt and Donini, {Lorenzo M} and Marcello Maggio and Tony Mets and Wijers, {Sander L J} and Garthoff, {Jossie A} and Yvette Luiking and Cornel Sieber and Tommy Cederholm",
year = "2020",
month = "8",
day = "1",
doi = "10.1007/s40520-020-01519-x",
language = "English",
volume = "32",
pages = "1501--1514",
journal = "Aging Clinical and Experimental Research",
issn = "1594-0667",
publisher = "Springer Verlag",
number = "8",

}

RIS

TY - JOUR

T1 - Safety and tolerability of 6-month supplementation with a vitamin D, calcium and leucine-enriched whey protein medical nutrition drink in sarcopenic older adults

AU - PROVIDE Consortium

AU - Bauer, Jürgen M

AU - Mikušová, Lucia

AU - Verlaan, Sjors

AU - Bautmans, Ivan

AU - Brandt, Kirsten

AU - Donini, Lorenzo M

AU - Maggio, Marcello

AU - Mets, Tony

AU - Wijers, Sander L J

AU - Garthoff, Jossie A

AU - Luiking, Yvette

AU - Sieber, Cornel

AU - Cederholm, Tommy

PY - 2020/8/1

Y1 - 2020/8/1

N2 - 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.

AB - 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.

KW - Nutrition

KW - Safety

KW - Sarcopenia

KW - Tolerability

KW - Vitamin D;

KW - Whey protein

UR - http://www.scopus.com/inward/record.url?scp=85082002399&partnerID=8YFLogxK

U2 - 10.1007/s40520-020-01519-x

DO - 10.1007/s40520-020-01519-x

M3 - Article

C2 - 32162241

VL - 32

SP - 1501

EP - 1514

JO - Aging Clinical and Experimental Research

JF - Aging Clinical and Experimental Research

SN - 1594-0667

IS - 8

ER -

ID: 49975956