维生素D和富含亮氨酸的乳清蛋白营养补充剂对老年人肌肉减少症指标的影响，PROVIDE研究：一项随机、双盲、安慰剂对照试验。

Effects of a vitamin D and leucine-enriched whey protein nutritional supplement on measures of sarcopenia in older adults, the PROVIDE study: a randomized, double-blind, placebo-controlled trial.

作者信息

Bauer Jürgen M, Verlaan Sjors, Bautmans Ivan, Brandt Kirsten, Donini Lorenzo M, Maggio Marcello, McMurdo Marion E T, Mets Tony, Seal Chris, Wijers Sander L, Ceda Gian Paolo, De Vito Giuseppe, Donders Gilbert, Drey Michael, Greig Carolyn, Holmbäck Ulf, Narici Marco, McPhee Jamie, Poggiogalle Eleonora, Power Dermot, Scafoglieri Aldo, Schultz Ralf, Sieber Cornel C, Cederholm Tommy

机构信息

Department of Geriatric Medicine, Carl von Ossietzky University, Oldenburg, Germany.

Nutricia Research, Nutricia Advanced Medical Nutrition, Utrecht, The Netherlands; Department of Internal Medicine, Section of Gerontology and Geriatrics, VU University Medical Center, Amsterdam, The Netherlands.

出版信息

J Am Med Dir Assoc. 2015 Sep 1;16(9):740-7. doi: 10.1016/j.jamda.2015.05.021. Epub 2015 Jul 10.

DOI:10.1016/j.jamda.2015.05.021

PMID:26170041

Abstract

BACKGROUND

Age-related losses of muscle mass, strength, and function (sarcopenia) pose significant threats to physical performance, independence, and quality of life. Nutritional supplementation could positively influence aspects of sarcopenia and thereby prevent mobility disability.

OBJECTIVE

To test the hypothesis that a specific oral nutritional supplement can result in improvements in measures of sarcopenia.

DESIGN

A multicenter, randomized, controlled, double-blind, 2 parallel-group trial among 380 sarcopenic primarily independent-living older adults with Short Physical Performance Battery (SPPB; 0-12) scores between 4 and 9, and a low skeletal muscle mass index. The active group (n = 184) received a vitamin D and leucine-enriched whey protein nutritional supplement to consume twice daily for 13 weeks. The control group (n = 196) received an iso-caloric control product to consume twice daily for 13 weeks. Primary outcomes of handgrip strength and SPPB score, and secondary outcomes of chair-stand test, gait speed, balance score, and appendicular muscle mass (by DXA) were measured at baseline, week 7, and week 13 of the intervention.

RESULTS

Handgrip strength and SPPB improved in both groups without significant between-group differences. The active group improved more in the chair-stand test compared with the control group, between-group effect (95% confidence interval): -1.01 seconds (-1.77 to -0.19), P = .018. The active group gained more appendicular muscle mass than the control group, between-group effect: 0.17 kg (0.004-0.338), P = .045.

CONCLUSIONS

This 13-week intervention of a vitamin D and leucine-enriched whey protein oral nutritional supplement resulted in improvements in muscle mass and lower-extremity function among sarcopenic older adults. This study shows proof-of-principle that specific nutritional supplementation alone might benefit geriatric patients, especially relevant for those who are unable to exercise. These results warrant further investigations into the role of a specific nutritional supplement as part of a multimodal approach to prevent adverse outcomes among older adults at risk for disability.

摘要

背景

与年龄相关的肌肉质量、力量和功能丧失（肌肉减少症）对身体机能、独立性和生活质量构成重大威胁。营养补充可能会对肌肉减少症的各个方面产生积极影响，从而预防行动能力障碍。

目的

检验特定口服营养补充剂可改善肌肉减少症相关指标这一假设。

设计

一项多中心、随机、对照、双盲、2平行组试验，纳入380名肌肉减少症患者，这些老年人主要为独立生活，短身体性能测试电池（SPPB；0 - 12）评分在4至9分之间，且骨骼肌质量指数较低。干预组（n = 184）每日服用两次富含维生素D和亮氨酸的乳清蛋白营养补充剂，持续13周。对照组（n = 196）每日服用两次等热量对照产品，持续13周。在干预的基线、第7周和第13周测量握力和SPPB评分的主要结局指标，以及椅子站立测试、步速、平衡评分和四肢肌肉质量（通过双能X线吸收法测量）的次要结局指标。

结果

两组的握力和SPPB均有所改善，组间差异无统计学意义。与对照组相比，干预组在椅子站立测试中的改善更为明显，组间效应（95%置信区间）：-1.01秒（-1.77至-0.19），P = 0.018。干预组比对照组增加了更多的四肢肌肉质量，组间效应：0.17千克（0.004 - 0.338），P = 0.045。