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
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 e cacy 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.
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