Sawada Yoko, Sugimoto Atsushi, Hananouchi Takehito, Sato Norimasa, Nagaoka Isao
Technology Research and Development Laboratory, Research and Development Headquarters, Asahi Group Foods, Ltd., Moriya, Ibaraki 302-0106, Japan.
Medical Engineering Laboratory, Department of Mechanical Engineering, Faculty of Engineering, Osaka Sangyo University, Osaka 574-8530, Japan.
Exp Ther Med. 2017 Nov;14(5):4561-4571. doi: 10.3892/etm.2017.5064. Epub 2017 Aug 29.
The aim of the present study was to assess the efficacy and safety of the oral administration of extract (ADE) supplement to individuals with knee discomfort associated with physical activity. A randomized, double-blind, placebo-controlled study was conducted using 48 subjects. The subjects were randomly allocated to an ADE diet group (oral administration of ADE-containing diet, n=24) or a placebo group (n=24), and the intervention was conducted for 12 weeks. A total of 22 subjects in the placebo group and 22 subjects in the ADE diet group were assessed to be eligible for assessment of the efficacy of supplement. Knee function was assessed by changes in the scores of the Japanese Knee Osteoarthritis Measure (JKOM) questionnaire and the scores of the Japan Orthopedic Association (JOA) criteria, as well as by analyzing the levels of type II collagen synthesis and degradation biomarkers (procollagen II C-terminal propeptide, cross-linked C-telopeptide of type II collagen, collagen type II cleavage and matrix metalloproteinase-13). Outcomes were measured at the baseline and at 4, 8 and 12 weeks from the start of administration. Subscale II (joint flexion/stiffness) of the JOA criteria was markedly improved in the ADE diet group compared with the placebo group at 8 and 12 weeks during the intervention. Furthermore, in the subgroup analyses using subjects with mild knee discomfort, subscale II (pain/stiffness) and IV (general activities) scores of JKOM were significantly improved (P<0.05) and total JKOM score was markedly improved in the ADE diet group compared with the placebo group at week 8 of the intervention. No adverse effects were identified for the administration of ADE. In conclusion, these observations suggest that the administration of an ADE-containing diet is safe and improves joint function (flexion and stiffness) and general activity in subjects with mild knee discomfort. Therefore, ADE could be a promising candidate as a functional food that is beneficial to joint health.
本研究的目的是评估口服提取物（ADE）补充剂对与体育活动相关的膝关节不适个体的疗效和安全性。使用48名受试者进行了一项随机、双盲、安慰剂对照研究。受试者被随机分配到ADE饮食组（口服含ADE的饮食，n = 24）或安慰剂组（n = 24），并进行了12周的干预。安慰剂组的22名受试者和ADE饮食组的22名受试者被评估为有资格评估补充剂的疗效。通过日本膝关节骨关节炎测量（JKOM）问卷得分和日本骨科协会（JOA）标准得分的变化，以及分析II型胶原合成和降解生物标志物（前胶原II C末端前肽、II型胶原交联C末端肽、II型胶原裂解和基质金属蛋白酶-13）的水平来评估膝关节功能。在给药开始时的基线以及第4、8和12周测量结果。在干预期间的第8周和第12周，与安慰剂组相比，ADE饮食组的JOA标准II亚量表（关节屈曲/僵硬）有明显改善。此外，在使用轻度膝关节不适受试者的亚组分析中，在干预第8周时，与安慰剂组相比，ADE饮食组的JKOM II亚量表（疼痛/僵硬）和IV亚量表（一般活动）得分显著改善（P<0.05），JKOM总分明显改善。未发现ADE给药有不良反应。总之，这些观察结果表明，给予含ADE的饮食是安全的，并能改善轻度膝关节不适受试者的关节功能（屈曲和僵硬）以及一般活动。因此，ADE作为一种有益于关节健康的功能性食品，可能是一个有前途的候选产品。
