Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium.
Department of Geriatric medicine, UZ Leuven, Leuven, Belgium.
BMC Geriatr. 2020 Dec 10;20(1):532. doi: 10.1186/s12877-020-01900-5.
The Exercise and Nutrition for Healthy AgeiNg (ENHANce) project aims to assess the combined effects of exercise and nutritional interventions to prevent loss of skeletal muscle mass and function with ageing, and to determine the underlying mechanisms of action.
One hundred eightycommunity-dwelling sarcopenic individuals (≥ 65 years) are allocated in a randomized controlled trial (RCT) in a 1:1 ratio into five groups for a 12-week intervention period, followed by a 12-week follow-up period: 1) exercise intervention +protein placebo +omega-3 fatty acids placebo; 2) protein +omega-3 fatty acids placebo; 3) exercise intervention +protein +omega-3 fatty acids placebo; 4) exercise intervention +protein +omega-3 fatty acids; 5) protein placebo +omega-3 fatty acids placebo. All interventions are in line with recommendations of expert groups such as the American College of Sports Medicine and the PROT-AGE study group and individualized to the physical capabilities and nutritional intake of each participant. Sarcopenia is diagnosed by the assessment of gait speed, handgrip strength (Jamar handheld dynamometer), chair stand test and muscle mass (DXA) according to the European Working Group on Sarcopenia in Older People (EWGSOP2) criteria. Participants, researchers and statisticians are blinded to omega-3 fatty acids and protein treatment. Compliance to the exercise program, protein and omega-3 fatty acids interventions is objectively measured, by monitoring movement by an activity monitor, determining nitrogen content in urine and analyzing the fatty acid composition of the red blood cell membrane. The primary outcome of the RCT is the change in Short Physical Performance Battery (SPPB) score. Secondary endpoints are, among others, changes in muscle mass, strength and function, objective compliance to interventions, changes in muscle and blood biomarkers related to sarcopenia, cognition, quality of life and falls.
This RCT in well-defined sarcopenic older adults assesses the effects of combined anabolic interventions, including the additive effects of omega-3 fatty acids supplements, compared to single or placebo interventions. Compliance with the exercise intervention and with the intake of nutritional supplements is measured objectively. Also, blood and muscle samples will be used to explore the underlying determinants that contribute to the mechanism of action of anabolic interventions.
Clinicaltrials.gov: NCT03649698 , retrospectively registered at 28 August 2018, first participant was randomized 16 February 2018.
运动与营养促进健康老龄化（ENHANCe）项目旨在评估运动和营养干预相结合，以防止随着年龄增长导致骨骼肌质量和功能的丧失，并确定其作用机制。
180 名社区居住的肌少症个体（≥65 岁）按照 1:1 的比例随机分配到 5 组进行为期 12 周的干预，随后进行 12 周的随访：1）运动干预+蛋白质安慰剂+ω-3 脂肪酸安慰剂；2）蛋白质+ω-3 脂肪酸安慰剂；3）运动干预+蛋白质+ω-3 脂肪酸安慰剂；4）运动干预+蛋白质+ω-3 脂肪酸；5）蛋白质安慰剂+ω-3 脂肪酸安慰剂。所有干预措施均符合美国运动医学学院和 PROT-AGE 研究小组等专家组的建议，并根据每个参与者的身体能力和营养摄入进行个体化调整。肌少症根据欧洲老年人肌少症工作组（EWGSOP2）标准评估步态速度、手握力（Jamar 手持式测力计）、椅子站立试验和肌肉质量（DXA）来诊断。参与者、研究人员和统计人员对 ω-3 脂肪酸和蛋白质治疗均不知情。通过监测活动监测器、测定尿液中的氮含量和分析红细胞膜的脂肪酸组成，客观地测量运动方案、蛋白质和 ω-3 脂肪酸干预的依从性。随机对照试验的主要结局是短体功表现电池（SPPB）评分的变化。次要终点包括肌肉质量、力量和功能的变化、干预措施的客观依从性、与肌少症相关的肌肉和血液生物标志物的变化、认知、生活质量和跌倒。
这项针对明确肌少症老年人的 RCT 评估了联合合成代谢干预的效果，包括 ω-3 脂肪酸补充剂的附加效果，与单一或安慰剂干预相比。运动干预和营养补充剂摄入的依从性是通过客观测量的。此外，还将使用血液和肌肉样本来探索有助于合成代谢干预作用机制的潜在决定因素。
Clinicaltrials.gov：NCT03649698，于 2018 年 8 月 28 日进行回顾性注册，首位参与者于 2018 年 2 月 16 日进行随机分组。
