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

Authors :
Mahendra Kumar Trivedi
Alice Branton
Dahryn Trivedi
Sambhu Mondal
Snehasis Jana
Source :
Frontiers in Psychiatry, Vol 13 (2022)
Publication Year :
2022
Publisher :
Frontiers Media S.A., 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 360TM) 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 360TM capsules twice a day. TRI 360TM 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 (p ≤ 0.0001) improved in TRI 360TM participants than placebo control group. Furthermore, significantly (p ≤ 0.001) increased levels of functional biomarkers: vitamin C and D3 metabolites, neurotransmitters, hormones, antiaging protein (klotho) level; and decreased proinflammatory cytokines and oxidative stress marker, malondialdehyde in TRI 360TM group than placebo. According to these findings, the use of TRI 360TM supplementation as a potentially safe therapeutic option for reducing psychological symptoms in healthy adults.

Details

Language :
English
ISSN :
16640640
Volume :
13
Database :
Directory of Open Access Journals
Journal :
Frontiers in Psychiatry
Publication Type :
Academic Journal
Accession number :
edsdoj.4b98ef96245847858295952360607ccf
Document Type :
article
Full Text :
https://doi.org/10.3389/fpsyt.2022.919284