METHODS: In this clinical trial, 85 subjects aged 35-60 yrs were diagnosed with photo-aged skin. Eighty-five subjects were randomized to receive either Tripep20 (n = 44) or placebo (n = 41). Seventy-eight subjects fully participating for a 12-week period consumed 1,000 mg of Tripep20 (n = 41) or placebo (n = 37) in a 50-mL bottle as a daily drink. The intend-to-treat and per-protocol populations were 85 and 78, respectively. Skin hydration, wrinkles, and elasticity were assessed at 0 (baseline), 6, and 12 weeks during the study period.
RESULTS: Skin hydration in the Tripep20 group was significantly higher from 6 weeks (P < 0.001) than the baseline. After 12 weeks, the Crow\'s-feet visual score and skin roughness (Ra, Rq, and Rmax) were significantly improved in the Tripep20 group than in the placebo group (P < 0.05). Consuming liquid collagen Tripep20 greatly enhanced skin elasticity (Gross R2, Net R5, and Biological elasticity R7) in 6 weeks compared to the placebo group. The Tripep20 group showed a significant increase in skin elasticity from the baseline after 6 and 12 weeks (P < 0.001). Neither abnormal symptoms nor adverse events were encountered during the study period in subjects ingesting Tripep20 or placebo. The changes in parameters related to hematology and clinical chemistry were within the normal ranges.
CONCLUSIONS: Oral consumption of liquid collagen Tripep20 was safe and well-tolerated. The results of this study show that freshwater fish-derived liquid collagen Tripep20 can be used as a healthy functional food ingredient to improve skin moisturizing, anti-wrinkling, and elasticity in an aging population.
方法:在这项临床试验中,85名35-60岁的受试者被诊断为照片老化的皮肤。85名受试者随机接受Tripep20(n=44)或安慰剂(n=41)。完全参与12周的78名受试者每天饮用50毫升瓶中的1,000毫克Tripep20(n=41)或安慰剂(n=37)。打算治疗和符合方案的人群分别为85和78。皮肤水合,皱纹,和弹性在0(基线)进行评估,研究期间的6周和12周。
结果:从6周开始,Tripep20组的皮肤水合作用明显高于基线(P<0.001)。12周后,乌鸦脚视觉评分和皮肤粗糙度(Ra,Rq,和Rmax)在Tripep20组比安慰剂组明显改善(P<0.05)。与安慰剂组相比,在6周内消耗液体胶原蛋白Tripep20大大增强了皮肤弹性(总R2,净R5和生物弹性R7)。在6周和12周后,Tripep20组的皮肤弹性比基线显着增加(P<0.001)。在摄入Tripep20或安慰剂的受试者中,在研究期间既没有发现异常症状也没有不良事件。与血液学和临床化学相关的参数变化在正常范围内。
结论:口服Tripep20液体胶原蛋白是安全且耐受性良好的。这项研究的结果表明,淡水鱼衍生的液体胶原蛋白Tripep20可以作为一种健康的功能食品成分,提高皮肤的保湿效果,抗皱,和人口老龄化的弹性。