UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054669 |
|---|---|
| Receipt number | R000062465 |
| Scientific Title | Measurement of Changes in GABA Concentration in the Human Brain Following Rosmarinic Acid Administration Using Magnetic Resonance Spectroscopy |
| Date of disclosure of the study information | 2024/06/15 |
| Last modified on | 2024/06/15 07:58:30 |
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Basic information
Public title
Measurement of Changes in GABA Concentration in the Human Brain Following Rosmarinic Acid Administration Using Magnetic Resonance Spectroscopy
Acronym
Measurement of Changes in GABA Concentration in the Human Brain Following Rosmarinic Acid Administration Using Magnetic Resonance Spectroscopy
Scientific Title
Measurement of Changes in GABA Concentration in the Human Brain Following Rosmarinic Acid Administration Using Magnetic Resonance Spectroscopy
Scientific Title:Acronym
Measurement of Changes in GABA Concentration in the Human Brain Following Rosmarinic Acid Administration Using Magnetic Resonance Spectroscopy
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Aiming to noninvasively measure changes in brain GABA levels before and after administration of rosmarinic acid in healthy subjects using magnetic resonance spectroscopy (MRS), thereby scientifically validating the pharmacological effects of rosmarinic acid.
Basic objectives2
Others
Basic objectives -Others
Changes in brain neurotransmitters
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in brain GABA concentration before and after administration of a rosmarinic acid-containing supplement, measured by MRS imaging.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Administration of a rosmarinic acid-containing supplement and MRI imaging
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 45 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Healthy individual
2.Having the capacity to consent (as it is necessary for the research subjects to have a full understanding of the study)
3.Being 18 years old or older, and under 45 years old
Key exclusion criteria
1.Diagnosed with a mental disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, Text Revision (DSM-5-TR)
2.Pregnant or breastfeeding women
3.History of physical dysfunction such as liver, kidney, or heart issues
4.Allergies to herbs, supplements, or polyphenols
5.Smokers
6.Currently taking medication
7.Having an implanted metal device such as a pacemaker (for safety reasons)
8.Head, neck, or body size not suitable for the MRI scanner (for safety reasons)
9.Having a tattoo larger than a one-point size, including tattoos and permanent makeup (for safety reasons)
10.Severe claustrophobia (for safety reasons)
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Uchida |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3971
hiroyuki_uchida@keio.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Uchida |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3971
Homepage URL
hiroyuki_uchida@keio.jp
Sponsor or person
Institute
Department of Neuropsychiatry, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Inokashira Hospital Foundation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine, Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-5363-3503
med-rinri-jimu@adst.keio.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 06 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 15 | Day |
Last modified on
| 2024 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062465
