General Anxiety DisordersNCT03935061
Effects of Mulberry Juice on Inflammatory Status and Clinical Symptoms in Patients With General Anxiety Disorder
A study testing Mulberry juice in people with General Anxiety Disorders and Systemic Inflammation, run by Taipei Medical University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- General Anxiety Disorders, Systemic Inflammation, Interleukin
- What is being tested?
- Mulberry juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Jul 2019to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- meet the criteria for GAD in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, as their primary diagnosis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University Shuang Ho Hospital
New Taipei City, 235
El-Wui Loh, PhD, 886903136037 ext. 886903136037, lohew@hotmail.com
About this study
Official title: Auxiliary Effects of Mulberry Juice on Inflammatory Status and Clinical Symptoms in Patients With General Anxiety Disorder: A Single-Blinded Trial
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.
Read the 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.
- Being tested
- Mulberry juice
- Keywords
- Anthocyanin, Anxiety Disorders, Inflammation, interleukin-17A
- Medical subject headings
- Generalized Anxiety Disorder, Anxiety Disorders, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulberry juiceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Anxiety Disorder-7 items (GAD-7)
GAD-7 measures anxiety status. The questionnaire is self-reported.
Measured: 5 to 10 minutes
Patient Health Questionnaire-9 items (PHQ-9)
PHQ-9 measure depression status. This questionnaire is self-reported.
Measured: 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.
Measured: 5 to 10 minutes
Secondary outcomes (2)
Inflammation markers
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.
Measured: 6 months
Inflammation genes
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start3 Jul 2019
- Primary completion30 Jun 2020 (estimated)
- Study completion31 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- El-Wui Loh, PhD, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935061
- Sponsor's protocol ID
- N201802079
- Status last verified
- Apr 2019
- First submitted
- 26 Apr 2019
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auxiliary Effects of Mulberry Juice on Inflammatory Status and Clinical Symptoms in Patients With General Anxiety Disorder: A Single-Blinded Trial
- ClinicalTrials.gov ID
- NCT03935061
- Acronym / sponsor ID
- N201802079
- Keywords
- Anthocyanin, Anxiety Disorders, Inflammation, interleukin-17A
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 2 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mulberry juice | Experimental | Other: Mulberry juiceTwo 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. |
| 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- meet the criteria for GAD in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, as their primary diagnosis
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mulberry juiceOn 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. | Other | Mulberry juice |
Primary outcome
General Anxiety Disorder-7 items (GAD-7)
Time frame: 5 to 10 minutes
GAD-7 measures anxiety status. The questionnaire is self-reported.
Patient Health Questionnaire-9 items (PHQ-9)
Time frame: 5 to 10 minutes
PHQ-9 measure depression status. This questionnaire is self-reported.
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.
2 secondary outcomes
Inflammation markers
Time frame: 6 months
Inflammation genes
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
El-Wui Loh, PhD principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mulberry juice in people with General Anxiety Disorders and Systemic Inflammation, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact El-Wui Loh, PhD (886-2-22490088 ext. 8898, lohew@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Anxiety Disorder-7 items (GAD-7) (time frame: 5 to 10 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2019.