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Safety and tolerabi...
Safety and tolerability of 6-month supplementation with a vitamin D, calcium and leucine-enriched whey protein medical nutrition drink in sarcopenic older adults
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- Bauer, Juergen M. (author)
- Heidelberg Univ, Ctr Geriatr Med, Agaples Bethanien Krankenhaus Heidelberg, Heidelberg, Germany
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- Mikusova, Lucia (author)
- Danone Nutricia Res, Nutricia Adv Med Nutr, Utrecht, Netherlands
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- Verlaan, Sjors (author)
- Univ Amsterdam, Med Ctr, VU, Dept Internal Med,Sect Gerontol & Geriatr, Amsterdam, Netherlands
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- Bautmans, Ivan (author)
- Vrije Univ Brussel, Frailty Ageing Res Grp FRIA, Brussels, Belgium
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- Brandt, Kirsten (author)
- Newcastle Univ, Inst Ageing, Sch Agr Food & Rural Dev, Human Nutr Res Ctr, Newcastle Upon Tyne, Tyne & Wear, England
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- Donini, Lorenzo M. (author)
- Sapienza Univ Rome, Dept Expt Med, Sect Med Pathophysiol Endocrinol & Human Nutr, Rome, Italy
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- Maggio, Marcello (author)
- Univ Parma, Sect Geriatr, Dept Clin & Expt Med, Parma, Italy
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- Mets, Tony (author)
- Vrije Univ Brussel, Frailty Ageing Res Grp FRIA, Brussels, Belgium
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- Wijers, Sander L. J. (author)
- Danone Nutricia Res, Nutricia Adv Med Nutr, Utrecht, Netherlands
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- Garthoff, Jossie A. (author)
- Danone Food Safety Ctr, Utrecht, Netherlands
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- Luiking, Yvette (author)
- Danone Nutricia Res, Nutricia Adv Med Nutr, Utrecht, Netherlands
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- Sieber, Cornel (author)
- Friedrich Alexander Univ Erlangen Nurnberg, Erlangen, Germany
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- Cederholm, Tommy (author)
- Karolinska Institutet,Uppsala universitet,Klinisk nutrition och metabolism,Geriatrik
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(creator_code:org_t)
- 2020-03-12
- 2020
- English.
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In: Aging Clinical and Experimental Research. - : Springer Nature. - 1594-0667 .- 1720-8319. ; 32:8, s. 1501-1514
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Abstract
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- 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 mu g 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Hälsovetenskap -- Näringslära (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Health Sciences -- Nutrition and Dietetics (hsv//eng)
Keyword
- Nutrition
- Safety
- Tolerability
- Sarcopenia
- Whey protein
- Vitamin D
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Bauer, Juergen M ...
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Mikusova, Lucia
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Verlaan, Sjors
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Bautmans, Ivan
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Brandt, Kirsten
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Donini, Lorenzo ...
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Maggio, Marcello
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Mets, Tony
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Wijers, Sander L ...
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Garthoff, Jossie ...
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Luiking, Yvette
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Sieber, Cornel
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Cederholm, Tommy
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Health Sciences
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and Nutrition and Di ...
- Articles in the publication
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Aging Clinical a ...
- By the university
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Uppsala University
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Karolinska Institutet