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

NCT03935061 | Unknown

• 1 other identifier: N201802079
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

General Anxiety Disorders; Systemic Inflammation; Interleukin

Keywords

Anthocyanin; Anxiety Disorders; Inflammation; interleukin-17A

Outcome Measures

Primary Outcomes (3)

• General Anxiety Disorder-7 items (GAD-7)

  GAD-7 measures anxiety status. The questionnaire is self-reported.

  5 to 10 minutes

• Patient Health Questionnaire-9 items (PHQ-9)

  PHQ-9 measure depression status. This questionnaire is self-reported.

  5 to 10 minutes

• World Health Organization Quality of Life - Brief (WHOQOL-BREF)

  WHOQOL-BREF measures the quality of life. The questionnaire is self-reported.

  5 to 10 minutes

Secondary Outcomes (2)

• Inflammation markers

  6 months

• Inflammation genes

  24 months

Study Arms (2)

Mulberry juice

EXPERIMENTAL

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

Controlled

NO INTERVENTION

Patients of the controlled group 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 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.

Interventions

Mulberry juice OTHER

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.

Mulberry juice

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University Shuang Ho Hospital

New Taipei City, 235, Taiwan

RECRUITING

MeSH Terms

Conditions

Generalized Anxiety Disorder; Anxiety Disorders; Inflammation

Condition Hierarchy (Ancestors)

Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• El-Wui Loh, PhD

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

El-Wui Loh, PhD

CONTACT

886-2-22490088; lohew@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The clinical assessments of clinical symptoms and social functions are self-reported and thus clinicians or care providers have no knowledge of the outcomes. The self-reported assessments are then coded by a research assistant with masked group labels and handled to the statistician for analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: May 2, 2019
• Study Start: July 3, 2019
• Primary Completion: June 30, 2020
• Study Completion: May 31, 2021
• Last Updated: September 11, 2019

Record last verified: 2019-04

Locations

TW (1)