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.

Leucine‐enriched whey protein supplementation, resistance‐based exercise, and cardiometabolic health in older adults: a randomized controlled trial

“…In line with experimental studies and meta‐analyses of older adults who are free of renal impairment, 31 , 32 , 33 , 34 increasing protein intake well‐beyond the RDA for 16 weeks did not exert beneficial nor harmful effects on kidney function (eGFR) or whole‐body bone mass (data not shown here). The inclusion of a marker of renal function is a novelty of our study given that only 4/13 of RCTs reported on this outcome at follow‐up as highlighted in a recent meta‐analysis 11 comparing the effects of high vs. low protein diets on cardiometabolic health.…”

The Optimal Strategy of Vitamin D for Sarcopenia: A Network Meta-Analysis of Randomized Controlled Trials

“…Finally, 16 references published for 9 RCTs met our eligibility criteria, after 40 references were excluded due to their protocols (k = 4), not RCT (k = 2), combination of medication (k = 1), and pre-sarcopenia (k = 33). All references of the nine RCTs were included ( Figure 1 ) [ 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 ].…”

Update on the ESCEO recommendation for the conduct of clinical trials for drugs aiming at the treatment of sarcopenia in older adults

“…Ageing is associated with anabolic resistance [69]. Factors such as protein intake, vitamin D/calcium, and the acid-base balance of the diet, play an important role in maintaining muscle mass and, muscle strength and physical performance [61,[70][71][72][73][74][75]. Poor nutritional status has therefore been recognised as one of the etiologic mechanisms contributing to sarcopenia [30].…”