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 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.

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“…In addition, safety follow‐up was conducted for 1 week (±2 days) after visit 4 (Figure 1). Same placebo control data were considered for different manuscripts for comparison of various parameters 8 …”

“…Body mass index (BMI) should be 18.5–30.0 kg/m, 2 calculated as weight in kg/(height in meters). Prior to enrollment, all subjects were screened by the principal investigator, subinvestigator, and physician for eligibility 8 …”

“…Participants were asked to withdraw if they met one of the following criteria: poor compliance (mean compliance <85% at the last estimation) or noncompliance and occurrence of a severe adverse effect 8 . The study discontinuation rate was meager in the blessing group (two subjects), and one subject was discontinued in the placebo group.…”

“…The collected serum samples were frozen at −20°C until all biomarkers analysis. All biomarkers levels were determined by parameter‐specific standard ELISA methods as per the manufacturer's instructions 8 …”

“…CD biomarkers (CD 8+ CD 28− ; CAT#564419), TNF‐α (CAT#558273), IL‐1β (CAT#558279), IL‐8 (CAT#558277), and IL‐6 (CAT#558276) ELISA‐based kits were obtained from BD Biosciences, USA and estimated by FACS Calibur, BD Biosciences. Vitamin C (CAT#E‐EL‐0011), 1, 25 dihydroxy vitamin D 3 (CAT#E‐EL‐0016), oxytocin (CAT#E‐EL‐0029), insulin, klotho (CAT#E‐EL‐H5451), oxidized LDL (CAT#E‐EL‐H0124), isoprostane (CAT#E‐EL‐0041), norepinephrine (CAT#E‐EL‐0047), dopamine (CAT#E‐EL‐0046), and acetylcholine (CAT#E‐EL‐0081) ELISA‐based kits were obtained from Elabscience Biotechnology Inc., and estimated by SpectraMax 190/SpectraMax M2e, Molecular Devices 8 …”