Jensen Gitte S, Attridge Victoria L, Lenninger Miki R, Benson Kathleen F
NIS Labs, Klamath Falls , Oregon, USA .
J Med Food. 2015 Jan;18(1):95-101. doi: 10.1089/jmf.2013.0174.
The goal for this study was to evaluate the effects of daily oral intake of a consumable liquid fermentate containing high-molecular-weight hyaluronan, as well as to perform a basic evaluation of safety and tolerability. A randomized, double-blind placebo-controlled study design was used to examine the effects of oral intake of hyaluronan on chronic pain conditions. Safety assessment included a complete blood count with differential, blood chemistry and electrocardiogram. The study duration was 4 weeks, where three tablespoons (45 mL) product or placebo was ingested during the first 2 weeks, and two tablespoons (30 mL) was consumed during the last 2 weeks. Seventy-eight people between the age of 19 and 71 years enrolled, and 72 people completed the study. Statistical analysis was performed using the two-tailed independent t-test for between-group significance and using the paired t-test for within-group significance. A reduction in pain scores was seen after 2 weeks of consumption of both placebo (P<.1) and active (P<.065) product; the reduction was more pronounced in the group consuming the active test product. Using "within-subject" analysis, a highly significant reduction in chronic pain scores was seen after 2 weeks of consumption of three tablespoons of active product (P<.001), whereas only a mild nonsignificant reduction in pain scores was seen in the placebo group. During the reduced intake for the last 2 weeks of study participation, pain scores showed a slight increase. During the last 2 weeks, a significant increase in the quality of sleep (P<.005) and level of physical energy (P<.05) was seen. The pain reduction during the initial 2 weeks was associated with significant reduction in the use of pain medication (P<.05). Consumption of an oral liquid formula containing high-molecular-weight hyaluronan was associated with relief of chronic pain.
本研究的目的是评估每日口服含高分子量透明质酸的可食用液体发酵物的效果,并对安全性和耐受性进行基本评估。采用随机、双盲、安慰剂对照研究设计,以检验口服透明质酸对慢性疼痛状况的影响。安全性评估包括血常规及分类、血液生化检查和心电图检查。研究为期4周,前2周摄入三汤匙(45毫升)产品或安慰剂,后2周摄入两汤匙(30毫升)。19至71岁的78人参与了研究,72人完成了研究。采用双尾独立t检验进行组间显著性统计分析,采用配对t检验进行组内显著性统计分析。服用安慰剂(P<0.1)和活性产品(P<0.065)2周后疼痛评分均有所降低;服用活性测试产品的组中疼痛评分降低更为明显。采用“受试者内”分析,服用三汤匙活性产品2周后慢性疼痛评分显著降低(P<0.001),而安慰剂组疼痛评分仅略有降低且无显著性差异。在研究参与的最后2周摄入量减少期间,疼痛评分略有上升。在最后2周,睡眠质量(P<0.005)和体力水平(P<0.05)显著提高。最初2周的疼痛减轻与止痛药物使用的显著减少有关(P<0.05)。口服含高分子量透明质酸的液体配方与慢性疼痛缓解有关。