Viewing Study NCT03935061



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Last Modification Date: 2024-10-26 @ 1:09 PM
Study NCT ID: NCT03935061
Status: UNKNOWN
Last Update Posted: 2019-09-11
First Post: 2019-04-26

Brief Title: Effects of Mulberry Juice on Inflammatory Status and Clinical Symptoms in Patients With General Anxiety Disorder
Sponsor: Taipei Medical University
Organization: Taipei Medical University

Study Overview

Official Title: Auxiliary Effects of Mulberry Juice on Inflammatory Status and Clinical Symptoms in Patients With General Anxiety Disorder A Single-Blinded Trial
Status: UNKNOWN
Status Verified Date: 2019-04
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Anxiety and depression are normally associated with inflammation reactions and interleukin IL related pathways are most evidently involved IL-17A interleukin 17A induces psoriasis-like inflammation and depression-like behaviors in animals and can be relieved by using IL-17A antibody Also human association studies found that IL-17A and certain downstream ILs are associated with the severity of anxiety IL-17A is a sentinel cytokine On binding with interleukin 17A receptor IL-17RA and interleukin 17C receptor IL-27RC it induces signaling cascades via nuclear factor kappa-light-chain-enhancer of activated B cells NFκB P38 mitogen-activated protein kinases p38MAPK and CCAAT-enhancer-binding proteins CEBPs knots and stimulates subsequent cell secretions of cytokines and chemokines Cyanidin 3-O-glucoside the main anthocyanin component of mulberry competes with IL-17A to bind its receptors and inhibits subsequent downstream cascades The investigators plan to use a single-blinded randomized controlled trial to evaluate the auxiliary effect of mulberry juice in general anxiety disorder including differences in psychiatric symptoms and levels of IL-related markers between the experimental and control groups and contribution of IL-related genes in the auxiliary effect
Detailed Description: The etiology pathogenesis and pathophysiology of psychiatric disorders are not limited to the brain Anxiety and depression are normally associated with inflammation reactions and interleukin IL related pathways are most evidently involved Previous animal studies showed that administration of IL-17A induces psoriasis-like inflammation and depression-like behavior and can be relieved by using IL-17A antibody while in humans association studies showed that serum IL-17A and certain downstream ILs are associated with the severity of anxiety Also the result of human genetic studies also identified several IL genes associated with anxiety and depression IL-17A is a sentinel cytokine On binding with interleukin 17A receptor IL-17RA and interleukin 17C receptor IL-27RC it induces signaling cascades via nuclear factor kappa-light-chain-enhancer of activated B cells NFκB P38 mitogen-activated protein kinases p38MAPK and CCAAT-enhancer-binding proteins CEBPs knots and stimulates subsequent cell secretions of cytokines and chemokines Many studies have demonstrated that consumption of proanthocyanidin-rich or anthocyanin-rich berries berries juice or other secondary products reduce a variety of inflammation symptoms in humans However these berries do not meet a low-cost requirement for general nutritional recommendation and new drug development in Taiwan due to the additional import cost On the other hand cyanidin 3-O-glucoside the main anthocyanin component of local mulberry competes with IL-17A to bind its receptors and inhibits subsequent downstream cascades Without interfering the on-going treatment of the patients this proposal plans to use a single-blinded randomized controlled trial to evaluate the auxiliary effect of mulberry juice in general anxiety disorder including differences in psychiatric symptoms anxiety depression and functions and levels of IL-related markers between the experimental and control groups and contribution of IL-related genes in the auxiliary effect

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None