Abstract
AimsSafety 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.MethodsA 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 discussionIn 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.ConclusionA 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.
Highlights
Sufficient dietary intake of protein, and an adequate vitamin D and calcium status has been proposed as a way to attenuate age-related loss of muscle and bone [1,2,3,4,5,6,7,8]
The Institute of Medicine in the USA and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) recommend a daily intake of 800 IU (= 20 μg) vitamin D3 for people of 71 years and older to sustain 25-hydroxyvitamin D levels above 50 nmol/L [5, 7, 13,14,15]
The aim of this post-hoc evaluation was to determine the effect of 6 months supplementation with a vitamin D, calcium and leucine-enriched whey protein medical nutrition drink (WP-MND) on kidney function and on vitamin D, parathyroid hormone (PTH) and calcium levels in sarcopenic older adults
Summary
Sufficient dietary intake of protein, and an adequate vitamin D and calcium status has been proposed as a way to attenuate age-related loss of muscle and bone [1,2,3,4,5,6,7,8]. An intervention with a vitamin D, calcium and leucine-enriched whey protein medical nutrition drink was shown to enhance muscle mass and improve lower-extremity function in sarcopenic older adults [19] To obtain these beneficial effects, two servings of the medical nutrition drink and thereby high amounts of protein (42 g), leucine (6 g), vitamin D (40 μg) and calcium (1000 mg) per day were consumed on top of the regular diet. Vitamin D or calcium toxicity related hypercalcemia may facilitate the formation of kidney stones and calcification of soft and vascular tissues, and result in acute symptoms such as nausea, vomiting, increased thirst and depression [21] The aim of this post-hoc evaluation was to determine the effect of 6 months supplementation with a vitamin D, calcium and leucine-enriched whey protein medical nutrition drink (WP-MND) on kidney function and on vitamin D, PTH and calcium levels in sarcopenic older adults. General safety was evaluated with parameters of liver function and registration of adverse events and tolerability was evaluated by a questionnaire addressing symptoms of gastrointestinal discomfort
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