Thirteen weeks of supplementation of vitamin D and leucine-enriched whey protein nutritional supplement attenuates chronic low-grade inflammation in sarcopenic older adults: the PROVIDE study

Liberman, Keliane; Njemini, Rose; Luiking, Yvette C.; Forti, Louis Nuvagah; Verlaan, Sjors; Bauer, Jüergen M.; Memelink, R.G.; Brandt, Kirsten; Donini, Lorenzo Maria; Maggio, Marcello; Mets, Tony; Wijers, S.; Sieber, Cornel; Cederholm, Tommy; Bautmans, Ivan

doi:10.1007/s40520-019-01208-4

Cited by 61 publications

(56 citation statements)

References 59 publications

(68 reference statements)

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“…On the other hand, a positive effect on cognitive outcomes was also observed, which is consistent with available literature on the effect of improved physical fitness from exercising on cognitive health 46 . Finally, the study not only confirmed that the intervention attenuates inflammation 19,47 —a factor contributing to sarcopenia 1,2,4,5 —but also clearly demonstrated for the first time that a high‐quality nutritional support in patients undergoing rehabilitation enables the achievement of improved physical function with substantial reduction in the costs of care. Although this was a secondary endpoint and a formal cost‐effectiveness analysis was not conducted, we could grossly estimate that a small investment in nutritional supplementation results in shorter LOS and physical therapy.…”

Section: Discussionsupporting

confidence: 87%

Improving rehabilitation in sarcopenia: a randomized‐controlled trial utilizing a muscle‐targeted food for special medical purposes

Rondanelli

Cereda

Klersy

et al. 2020

J cachexia sarcopenia muscle

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Background Sarcopenia is a disease associated with aging and a negative prognosis. Consensus-based treatment consists in targeting muscle mass and function through physical exercise, optimization of protein intake, and vitamin D supplementation, but evidence is lacking. We evaluated the safety and efficacy of a muscle-targeted nutritional support on the outcome of a physical exercise rehabilitation programme. Methods In a single-site, double-blind, randomized, controlled trial (NCT03120026; May 2017 to December 2018), old (≥65 years) adults [N = 140 (63% female patients; age, 81 ± 6 years)] without severe cognitive impairment, who were found to have sarcopenia by European Working Group on Sarcopenia in Older People 2010 criteria and hospitalized for physical rehabilitation, were randomized to receive until discharge (for at least 4 weeks and up to 8 weeks) a whey protein-based nutritional formula enriched with leucine and vitamin D or an iso-caloric control formula twice daily in addition to a standard hospital diet. The primary endpoint was the change in 4 m gait speed per month. Key secondary endpoints addressed the change in physical performance: chair-stand test, timed up and go test, and short physical performance battery. Other secondary outcomes were the change in functional status, muscle strength and mass, cognitive status, and quality of life. The proportion of patients who improved their rehabilitation intensity profile and overall economic benefits (using length of stay and duration of rehabilitation as surrogate measures) were also evaluated. Results A total of 161 patients were screened and 140 were randomized to study interventions. Thirteen patients (experimental, n = 6; placebo, n = 7) discontinued the intervention because they disliked the product and intention-to-treat analyses were based on patients reassessed at discharge [n = 127 (66% female patients; age, 81 ± 6 years)]. Supplementation with the experimental formula (n = 64) resulted in greater increase in mean gait speed {0.061 m/s/month [95% confidence interval (CI), 0.043 to 0.080]} than placebo [n = 63; À0.001 m/s/month (95%CI, À0.008 to 0.006)]: mean difference, 0.063 m/s/month (95% CI, 0.043 to 0.082) (P < 0.001). A significant effect was also found for muscle mass (P < 0.03) and all key secondary outcomes, functional and cognitive endpoints (P < 0.001 for all). Supplementation resulted also in higher proportion of patients improving their rehabilitation intensity profile (P = 0.003) and being discharged home (P = 0.002); shorter rehabilitation (P < 0.001); and hospital stay (P < 0.001). Conclusions In old adults with sarcopenia admitted to hospital for rehabilitation the consumption of a whey protein-based nutritional formula enriched with leucine and vitamin D improved physical performance and function, as well as muscle mass, and reduced the intensity and costs of care.

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Section: Discussionsupporting

confidence: 87%

Improving rehabilitation in sarcopenia: a randomized‐controlled trial utilizing a muscle‐targeted food for special medical purposes

Rondanelli

Cereda

Klersy

et al. 2020

J cachexia sarcopenia muscle

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“…Supplementation with at least 1000 IU/day of vitamin D may be needed to achieve this target while protecting bone health, as the bioavailability of this micronutrient deteriorates in geriatric patients. Of notice, 13 weeks of a nutritional beverage (consisting of vitamin D and leucine‐enriched whey protein) increased appendicular lean (muscle) mass and chair‐stand speed and attenuated markers of inflammation in sarcopenic older adults. However, a larger study showed no benefit of whey protein supplementation on curbing declines in muscle mass and physical function in sarcopenic older adults, although compliance with the supplement was ~58%, which corroborates another study displaying the difficulties of supplementing in this population.…”

Section: Treatment: Progressive Resistance and Balance Exercises And mentioning

confidence: 99%

Osteosarcopenia: epidemiology, diagnosis, and treatment—facts and numbers

Kirk

Zanker

Duque

2020

J cachexia sarcopenia muscle

240

244

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Background Osteosarcopenia, the presence of osteopenia/osteoporosis and sarcopenia, is an emerging geriatric giant, which poses a serious global health burden. Methods and results The prevalence of osteosarcopenia ranges in community‐dwelling older adults [5–37% (≥65 years)] with the highest rates observed in those with fractures (low‐trauma fracture: ~46%; hip fracture: 17.1–96.3%). Among 2353 community‐dwelling adults, risk factors associated with osteosarcopenia include older age [men: 14.3% (60–64 years) to 59.4% (≥75 years); women: 20.3% (60–64 years) to 48.3% (≥75 years), P < 0.05], physical inactivity [inverse relationship: 0.64, 95% confidence interval (CI) 0.46–0.88 (sexes combined)], low body mass index (inverse relationship: men: 0.84, 95% CI 0.81–0.88; women: 0.77, 95% CI 0.74–0.80), and higher fat mass (men: 1.46, 95% CI 1.11–1.92; women: 2.25, 95% CI 1.71–2.95). Among 148 geriatric inpatients, osteosarcopenic individuals demonstrate poorer nutritional status (mini‐nutritional assessment scores: 8.50 ± 2.52 points, P < 0.001) vs. osteoporosis or sarcopenia alone, while among 253 older Australians, osteosarcopenia is associated with impaired balance and functional capacity [odds ratios (ORs): 2.56–7.19; P < 0.05] vs. non‐osteosarcopenia. Osteosarcopenia also associates with falls (ORs: 2.83–3.63; P < 0.05), fractures (ORs: 3.86–4.38; P < 0.05), and earlier death [hazard ratio (1‐year follow‐up): 1.84, 95% CI; 0.69–4.92, P = 0.023] vs. non‐osteosarcopenia. Conclusions This syndrome is expected to grow in age‐related and disease‐related states, a likely consequence of immunosenescence coinciding with increased sedentarism, obesity, and fat infiltration of muscle and bone. Evidence suggests the pathophysiology of osteosarcopenia includes genetic polymorphisms, reduced mechanical loading, and impaired endocrine functioning, as well as altered crosstalk between muscle, bone, and fat cells. Clinicians should screen for osteosarcopenia via imaging methods (i.e. dual‐energy X‐ray absorptiometry) to quantify muscle and bone mass, in addition to assessing muscle strength (i.e. grip strength) and functional capacity (i.e. gait speed). A comprehensive geriatric assessment, including medical history and risk factors, must also be undertaken. Treatment of this syndrome should include osteoporotic drugs [bone anabolics/antiresorptives (i.e. teriparatide, denosumab, bisphosphates)] where indicated, and progressive resistance and balance exercises (at least 2‐3 times/week). To maximize musculoskeletal health, nutritional recommendations [protein (1.2–1.5 g/kg/day), vitamin D (800–1000 IU/day), calcium (1300 mg/day), and creatine (3–5 g/day)] must also be met. It is anticipated that diagnosis and treatment for osteosarcopenia will become part of routine healthcare in the future. However, further work is required to identify biomarkers, which, in turn, may increase diagnosis, risk stratification, and targeted treatments to improve health outcomes.

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“…As described in detail before [19,22], participants were recruited from 18 study centers in 6 European countries. Older adults (≥ 65 years) were eligible when they suffered from sarcopenia, defined as low skeletal muscle mass index (SMI) combined with mild to moderate limitations in physical performance (for definitions applied see reference [19]).…”

Section: Participantsmentioning

confidence: 99%

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

et al. 2020

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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 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.

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Thirteen weeks of supplementation of vitamin D and leucine-enriched whey protein nutritional supplement attenuates chronic low-grade inflammation in sarcopenic older adults: the PROVIDE study

Cited by 61 publications

References 59 publications

Improving rehabilitation in sarcopenia: a randomized‐controlled trial utilizing a muscle‐targeted food for special medical purposes

Improving rehabilitation in sarcopenia: a randomized‐controlled trial utilizing a muscle‐targeted food for special medical purposes

Osteosarcopenia: epidemiology, diagnosis, and treatment—facts and numbers

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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