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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

Effects of Mulberry Juice on Inflammatory Status and Clinical Symptoms in Patients With General Anxiety Disorder

Clinicaltrials.gov identifier NCT03935061

Recruitment Status Recruiting

First Posted May 2, 2019

Last update posted September 11, 2019

Study Description

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 (C/EBPs) 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.

  • Condition or Disease:General Anxiety Disorders
    Systemic Inflammation
    Interleukin
  • Intervention/Treatment: Other: Mulberry juice
  • Phase: N/A
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 (C/EBPs) 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 Design
  • Study Type: Interventional
  • Estimated Enrollment: 104 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Patients who agree to join our study are measured at baseline. Randomization is carried out by using a computer program and 2 bottles (600 ml/bottle) of sanitized mulberry juice are delivered to the experimental group 20 days before the next clinic visit, with instruction to consume 50 ml of juice diluted with drinking water at room temperature. For the control group, patients are informed of their allocation results along with a reminder of the next clinic visit. On the second visit at the 1st month, measurements of clinical symptoms and social functions and inflammation status are conducted. A between-group difference at this stage represents changes caused by the intervention. No mulberry juice is given to patients for either group further on. All patients are evaluated again with the same assessment tools, as well as the immunology markers in their sera during the third visit.
  • Masking: Double (Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Auxiliary Effects of Mulberry Juice on Inflammatory Status and Clinical Symptoms in Patients With General Anxiety Disorder: A Single-Blinded Trial
  • Actual Study Start Date: July 2019
  • Estimated Primary Completion Date: June 2020
  • Estimated Study Completion Date: May 2021
Arms and interventions
Arm Intervention/treatment
Experimental: Mulberry juice
Two bottles (600 ml/bottle) of sanitized mulberry juice are delivered to the patients of the experimental group 20 days before the next clinic visit, with instruction to consume 50 ml of juice diluted with drinking water at room temperature. A reminder of the next clinic visit for continuous treatment is attached.
Other: Mulberry juice
On the second visit at the 1st month, measurements of clinical symptoms and inflammation status are conducted. No mulberry juice is given to patients further on. All patients are evaluated again with the same assessment tools, as well as the immunology markers in their sera during the third visit.
Outcome Measures
  • Primary Outcome Measures: 1. General Anxiety Disorder-7 items (GAD-7) [ Time Frame: 5 to 10 minutes ]
    GAD-7 measures anxiety status. The questionnaire is self-reported.
  • 2. Patient Health Questionnaire-9 items (PHQ-9) [ Time Frame: 5 to 10 minutes ]
    PHQ-9 measure depression status. This questionnaire is self-reported.
  • 3. World Health Organization Quality of Life - Brief (WHOQOL-BREF) [ Time Frame: 5 to 10 minutes ]
    WHOQOL-BREF measures the quality of life. The questionnaire is self-reported.
  • Secondary Outcome Measures: 1. Inflammation markers [ Time Frame: 6 months ]
    Inflammation status of the patients are evaluated by measuring CRP, known cytokines (Interleukin- 6 [IL-6], Interleukin-1β [IL-1β], tumor necrosis factor-α (TNF-α), granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF], and transforming growth factor [TGF-β]), chemokines (IL-8, GRO-α, and MCP-1), and PGE in sera, in addition to the sentinel molecule IL-17A. All markers are measured by using ELISA assays according to manufacturer instructions.
  • 2. Inflammation genes [ Time Frame: 24 months ]
    Inflammation genes including CRP, cytokines (IL-6, IL-1β, TNF-α, G-CSF, GM-CSF, and TGF-β), chemokines (IL-8, GRO-α, and MCP-1), and PGE in addition to IL-17A, are to be genotyped.
Eligibility Criteria
  • Ages Eligible for Study: 20 to 65 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

• meet the criteria for GAD in the Diagnostic and Statistical Manual of Mental Disorders,
5th Edition, as their primary diagnosis

Exclusion Criteria:

- severe physical diseases that required intensive care or additional medical attention
such as terminal cancer, stroke, and end-stage renal disease

- psychotic symptoms or recent suicide attempts

Contacts and Locations
Contacts

Contact: El-Wui Loh, PhD 886-2-22490088 ext 8898 lohew@hotmail.com

Locations

Taiwan
Taipei Medical University Shuang Ho Hospital
New Taipei City

Sponsors and Collaborators

Taipei Medical University

Investigators

Principal Investigator: El-Wui Loh, PhD Taipei Medical University

More Information
  • Responsible Party: Taipei Medical University
  • ClinicalTrials.gov Identifier: NCT03935061 History of Changes
  • Other Study ID Numbers: N201802079
  • First Posted: May 2, 2019 Key Record Dates
  • Last Update Posted: September 11, 2019
  • Last Verified: April 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Taipei Medical University: Anthocyanin
    Anxiety Disorders
    Inflammation
    interleukin-17A
  • Additional relevant MeSH terms: Inflammation
    Disease
    Anxiety Disorders