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一种新型专利膳食补充剂(TRI 360)对成年受试者心理症状及与压力相关生活质量的疗效:一项随机对照临床试验。

Efficacy of a novel proprietary dietary supplement (TRI 360) on psychological symptoms and stress-related quality of life in adult subjects: A randomized controlled clinical trial.

作者信息

Trivedi Mahendra Kumar, Branton Alice, Trivedi Dahryn, Mondal Sambhu, Jana Snehasis

机构信息

Trivedi Global, Inc., Henderson, NV, United States.

Trivedi Science Research Laboratory Pvt. Ltd., Thane, India.

出版信息

Front Psychiatry. 2022 Aug 11;13:919284. doi: 10.3389/fpsyt.2022.919284. eCollection 2022.

Abstract

Nowadays, diet plays an increasingly important role in normal physiology and mental health. Recently, many studies have shown that more use of dietary supplements in mental and psychological disorders. Study objective was to investigate safety and efficacy of proprietary nutraceutical combination (TRI 360) on psychological symptoms in adult human subjects with one or more psychological symptoms in open-label, single-center, parallel-group, randomized controlled trial. Eighty-four participants aged 20-45 years with psychological symptoms were completed this trial. Participants were randomly assigned to placebo and treatment groups. Treatment group received TRI 360 capsules twice a day. TRI 360 was well-tolerated and didn't show treatment-related adverse-events upto 180 days. All assessed perception scorings on psychological symptoms like fatigue, mental stress, sleep disturbance, anxiety, depression, emotional trauma, mood changes, self-confidence, willpower, and motivation were very significantly ( ≤ 0.0001) improved in TRI 360 participants than placebo control group. Furthermore, significantly ( ≤ 0.001) increased levels of functional biomarkers: vitamin C and D metabolites, neurotransmitters, hormones, antiaging protein (klotho) level; and decreased proinflammatory cytokines and oxidative stress marker, malondialdehyde in TRI 360 group than placebo. According to these findings, the use of TRI 360 supplementation as a potentially safe therapeutic option for reducing psychological symptoms in healthy adults.

摘要

如今,饮食在正常生理和心理健康中发挥着越来越重要的作用。最近,许多研究表明,在精神和心理障碍中更多地使用膳食补充剂。研究目的是在开放标签、单中心、平行组、随机对照试验中,调查一种专利营养组合(TRI 360)对有一个或多个心理症状的成年人类受试者心理症状的安全性和有效性。84名年龄在20至45岁有心理症状的参与者完成了该试验。参与者被随机分配到安慰剂组和治疗组。治疗组每天服用两次TRI 360胶囊。TRI 360耐受性良好,在长达180天的时间里未出现与治疗相关的不良事件。与安慰剂对照组相比,TRI 360组所有评估的心理症状感知评分,如疲劳、精神压力、睡眠障碍、焦虑、抑郁、情感创伤、情绪变化、自信、意志力和动机,均有非常显著(≤0.0001)的改善。此外,与安慰剂相比,TRI 360组功能性生物标志物水平显著(≤0.001)升高:维生素C和D代谢物、神经递质、激素、抗衰老蛋白(klotho)水平;促炎细胞因子和氧化应激标志物丙二醛水平降低。根据这些发现,使用TRI 360补充剂作为一种潜在安全的治疗选择,可减轻健康成年人的心理症状。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8c02/9403741/7771092ce442/fpsyt-13-919284-g0001.jpg

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