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

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 (T...

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Autores principales: Trivedi, Mahendra Kumar, Branton, Alice, Trivedi, Dahryn, Mondal, Sambhu, Jana, Snehasis
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9403741/
https://www.ncbi.nlm.nih.gov/pubmed/36032243
http://dx.doi.org/10.3389/fpsyt.2022.919284
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author Trivedi, Mahendra Kumar
Branton, Alice
Trivedi, Dahryn
Mondal, Sambhu
Jana, Snehasis
author_facet Trivedi, Mahendra Kumar
Branton, Alice
Trivedi, Dahryn
Mondal, Sambhu
Jana, Snehasis
author_sort Trivedi, Mahendra Kumar
collection PubMed
description 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(TM)) 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(TM) capsules twice a day. TRI 360(TM) 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 360(TM) participants than placebo control group. Furthermore, significantly (p ≤ 0.001) increased levels of functional biomarkers: vitamin C and D(3) metabolites, neurotransmitters, hormones, antiaging protein (klotho) level; and decreased proinflammatory cytokines and oxidative stress marker, malondialdehyde in TRI 360(TM) group than placebo. According to these findings, the use of TRI 360(TM) supplementation as a potentially safe therapeutic option for reducing psychological symptoms in healthy adults.
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spelling pubmed-94037412022-08-26 Efficacy of a novel proprietary dietary supplement (TRI 360(TM)) on psychological symptoms and stress-related quality of life in adult subjects: A randomized controlled clinical trial Trivedi, Mahendra Kumar Branton, Alice Trivedi, Dahryn Mondal, Sambhu Jana, Snehasis Front Psychiatry Psychiatry 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(TM)) 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(TM) capsules twice a day. TRI 360(TM) 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 360(TM) participants than placebo control group. Furthermore, significantly (p ≤ 0.001) increased levels of functional biomarkers: vitamin C and D(3) metabolites, neurotransmitters, hormones, antiaging protein (klotho) level; and decreased proinflammatory cytokines and oxidative stress marker, malondialdehyde in TRI 360(TM) group than placebo. According to these findings, the use of TRI 360(TM) supplementation as a potentially safe therapeutic option for reducing psychological symptoms in healthy adults. Frontiers Media S.A. 2022-08-11 /pmc/articles/PMC9403741/ /pubmed/36032243 http://dx.doi.org/10.3389/fpsyt.2022.919284 Text en Copyright © 2022 Trivedi, Branton, Trivedi, Mondal and Jana. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Psychiatry
Trivedi, Mahendra Kumar
Branton, Alice
Trivedi, Dahryn
Mondal, Sambhu
Jana, Snehasis
Efficacy of a novel proprietary dietary supplement (TRI 360(TM)) on psychological symptoms and stress-related quality of life in adult subjects: A randomized controlled clinical trial
title Efficacy of a novel proprietary dietary supplement (TRI 360(TM)) on psychological symptoms and stress-related quality of life in adult subjects: A randomized controlled clinical trial
title_full Efficacy of a novel proprietary dietary supplement (TRI 360(TM)) on psychological symptoms and stress-related quality of life in adult subjects: A randomized controlled clinical trial
title_fullStr Efficacy of a novel proprietary dietary supplement (TRI 360(TM)) on psychological symptoms and stress-related quality of life in adult subjects: A randomized controlled clinical trial
title_full_unstemmed Efficacy of a novel proprietary dietary supplement (TRI 360(TM)) on psychological symptoms and stress-related quality of life in adult subjects: A randomized controlled clinical trial
title_short Efficacy of a novel proprietary dietary supplement (TRI 360(TM)) on psychological symptoms and stress-related quality of life in adult subjects: A randomized controlled clinical trial
title_sort efficacy of a novel proprietary dietary supplement (tri 360(tm)) on psychological symptoms and stress-related quality of life in adult subjects: a randomized controlled clinical trial
topic Psychiatry
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9403741/
https://www.ncbi.nlm.nih.gov/pubmed/36032243
http://dx.doi.org/10.3389/fpsyt.2022.919284
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