Effects of Curcumin C3 Complex® on Physical Function in Moderately Functioning Older Adults with Low-Grade Inflammation - A Pilot Trial.

Pub Date : 2023-01-01 DOI:10.14283/jfa.2022.47
R T Mankowski, K T Sibille, C Leeuwenburgh, Y Lin, F-C Hsu, P Qiu, B Sandesara, S D Anton
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Abstract

Background: Natural dietary compounds that can modulate the inflammation process have the potential to improve physical function through a number of biological pathways, and thus may represent an alternative approach to avert functional decline compared to more time-burdening lifestyle interventions. In this pilot trial, we tested the feasibility and explored the effect of a nutritional compound, Curcumin C3 Complex® for improving physical function and muscle strength in moderately functioning older adults with low-grade inflammation.

Methods: Moderately functioning (short physical performance battery, SPPB <10) and sedentary older adults (>65 years) with low-grade systemic inflammation (c-reactive protein >1mg/dL) were randomized to receive Curcumin C3 Complex® (n=9) (1000mg/day) or placebo (n=8) groups for 12 weeks. All participants (age range: 66-94 years, 8 females and 9 males) underwent functional testing (SPPB and walking speed by the 400-meter walk test) and lower-limb strength (knee flexion and extension peak torque by the Biodex test) at baseline and 12 weeks. Venous blood was collected at baseline, 4, 8 and 12 weeks for safety blood chemistry analyses and biomarkers of inflammation.

Results: A total of 17 participants were randomized and completed the study. Adherence was high (> 90%) and there were no adverse events reported or abnormal blood chemistries reported. Based on effect sizes, participants in the Curcumin C3 Complex® group demonstrated large effect sizes in the SPPB (Cohen's effect size d=0.75) and measures of knee extension (d=0.69) and flexion peak torque (d=0.82). Effect sizes for galectin-3 (d=-0.31) (larger decrease) and interleukin-6 (d=0.38) (smaller increase) were small in the Curcumin C3 Complex® group compared to placebo.

Conclusion: This pilot trial suggests that there were no difficulties with recruitment, adherence and safety specific to the study protocol. Preliminary findings warrant a Phase IIb clinical trial to test the effect of Curcumin C3 Complex® on physical function and muscle strength in older adults at risk for mobility disability.

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姜黄素 C3 Complex® 对患有低度炎症的中度老年人身体功能的影响--一项试点试验。
背景:能够调节炎症过程的天然膳食化合物有可能通过多种生物途径改善身体功能,因此与耗时较长的生活方式干预相比,它可能是避免功能衰退的另一种方法。在这项试验中,我们测试了姜黄素 C3 Complex® 营养复合物改善患有低度炎症的中度老年人身体功能和肌肉力量的可行性,并探讨了其效果:将患有低度全身性炎症(c-反应蛋白>1mg/dL)的中度功能性老年人(短期体能测试,SPPB 65 岁)随机分为姜黄素 C3 Complex® 组(9 人)(1000 毫克/天)或安慰剂组(8 人),为期 12 周。所有参与者(年龄范围:66-94 岁,女性 8 人,男性 9 人)均在基线和 12 周时接受了功能测试(400 米步行测试中的 SPPB 和步行速度)和下肢力量测试(Biodex 测试中的膝关节屈伸峰值扭矩)。在基线、4周、8周和12周时采集静脉血,进行安全血液化学分析和炎症生物标志物分析:共有 17 名参与者被随机分配并完成了研究。研究的依从性很高(> 90%),没有不良反应或血液化学成分异常的报告。根据效应大小,姜黄素 C3 Complex® 组的参与者在 SPPB(科恩效应大小 d=0.75)以及膝关节伸展(d=0.69)和屈曲峰值扭矩(d=0.82)方面表现出较大的效应大小。与安慰剂相比,莪术 C3 Complex® 组的半整联蛋白-3(d=-0.31)(降幅较大)和白细胞介素-6(d=0.38)(升幅较小)的效应大小较小:这项试点试验表明,研究方案在招募、依从性和安全性方面没有具体困难。初步研究结果证明,有必要进行 IIb 期临床试验,以测试姜黄素 C3 Complex® 对有行动不便风险的老年人的身体功能和肌肉力量的影响。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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