目的:骨骼肌是关节健康的重要因素。先前的研究表明,与年龄相关的肌肉质量和力量损失与膝骨关节炎的发展密切相关。这项研究的目的是研究高植物蛋白/肽营养补充剂是否可以通过改善肌肉质量和力量来缓解膝骨关节炎。
方法:这是随机的,双盲,本试验于2022年2月至2022年9月在中国进行了安慰剂对照试验,纳入50-70岁被诊断为膝骨关节炎和肌肉减少症的参与者(ChiCTR2200056415).参与者被随机分配接受为期12周的高植物蛋白/肽营养补充剂或安慰剂,每天两次。早餐和晚餐后每人一份,分别。使用意向治疗分析分析的主要结果是两组之间从基线到第12周的短物理性能电池(SPPB)的差异。次要结果包括肌肉质量的变化,力量,膝骨关节炎的症状和影像学,身体成分,生化参数,和健康质量评分。
结果:12周后,共有124例参与者(38.7%为男性)完成试验,并纳入最终分析.在12周的随访中,实验组与安慰剂组相比,SPPB总分有显著改善(1.03,95%CI,0.69~1.38,P<0.0001).握力(2.83kg,相对于安慰剂组,实验组的95%CI,2.13至3.53,P<0.0001)和骨骼肌质量指数(0.66kg/m2,95%CI,0.45至0.86,P<0.0001)也显着增加。试验组西部安大略省和麦克马斯特大学骨关节炎指数总分的平均变化为-3.95分(95%CI,-5.02至-2.89,P<0.0001),安慰剂组为0.23分(95%CI,-0.17至0.63,P=0.253)。此外,在实验组中,九名参与者经历了骨赘磁共振成像结果的改善,而安慰剂组未观察到改善。与安慰剂组相比,实验组的健康质量也有显著改善,如世界卫生组织生命质量简表36,和Chalder疲劳量表。试验期间未报告严重不良事件。
结论:口服补充高水平的植物蛋白/肽可以缓解患有轻度或轻度膝骨关节炎和肌肉减少症的老年人的骨关节炎症状。这种改善可能归因于肌肉质量的增强,力量,和物理性能。
OBJECTIVE: Skeletal muscle is an important contributor to joint health. Previous studies have shown that age-related muscle mass and strength loss are closely associated with the development of knee osteoarthritis. The objective of this study is to investigate whether a high plant protein/peptide nutrition supplementation can alleviate knee osteoarthritis by improving muscle mass and strength.
METHODS: This randomized, double-blind, placebo-controlled trial that included participants aged 50-70 years diagnosed with knee osteoarthritis and sarcopenia was conducted in China from February 2022 to September 2022 (ChiCTR2200056415). Participants were randomly assigned to receive either a 12-week high plant protein/peptide nutrition supplementation or a placebo twice daily, with one serving each after breakfast and dinner, respectively. The primary outcome analyzed using intention-to-treat analysis was difference in Short Physical Performance Battery (SPPB) from baseline to week 12 between the two groups. The secondary outcomes included changes in muscle mass, strength, symptom and imaging of knee osteoarthritis, body composition, biochemical parameters, and health quality scores.
RESULTS: After 12 weeks, a total of 124 participants (38.7% male) completed the trial and were included in the final analysis. Over the 12-week follow-up, the experimental group showed a significant improvement in the SPPB total score (1.03, 95% CI, 0.69 to 1.38, P < 0.0001) compared with the placebo group. Grip strength (2.83 kg, 95% CI, 2.13 to 3.53, P < 0.0001) and skeletal muscle mass index (0.66 kg/m2, 95% CI, 0.45 to 0.86, P < 0.0001) were also significantly increased in the experimental group relative to the placebo group. The mean change in Western Ontario and McMaster Universities Osteoarthritis Index total score was -3.95 points (95% CI, -5.02 to -2.89, P < 0.0001) in the experimental group and 0.23 points (95% CI, -0.17 to 0.63, P = 0.253) in the placebo group. Additionally, within the experimental group, nine participants experienced an improvement in osteophyte magnetic resonance imaging results, while no improvement was observed in the placebo group. The experimental group also exhibited significant improvements in health quality compared with the placebo group as assessed by Short Form 36, the World Health Organization Quality of Life Brief Scale, and the Chalder Fatigue Scale. No serious adverse events were reported during the trial.
CONCLUSIONS: Oral supplementation with high levels of plant protein/peptides can alleviate symptoms of osteoarthritis in elderly individuals with minor or mild knee osteoarthritis and sarcopenia. This improvement may be attributed to the enhancements of muscle mass, strength, and physical performance.