UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049361 |
|---|---|
| Receipt number | R000056214 |
| Scientific Title | A verification study to evaluate the safety of excessive consumption of the test food in human: an open-label trial |
| Date of disclosure of the study information | 2022/10/28 |
| Last modified on | 2023/12/15 13:01:26 |
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Basic information
Public title
A verification study to evaluate the safety of excessive consumption of the test food in human
Acronym
A verification study to evaluate the safety of excessive consumption of the test food in human
Scientific Title
A verification study to evaluate the safety of excessive consumption of the test food in human: an open-label trial
Scientific Title:Acronym
A verification study to evaluate the safety of excessive consumption of the test food in human
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the safety of excessive consumption of the test food for four weeks in healthy Japanese subject
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Incidence of adverse events
Key secondary outcomes
1. The proportion of subjects whose values of blood test and urinalysis are outside the reference range after intervention despite within the reference range at screening (before consumption; Scr)
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
Duration: Four weeks
Test food: Capsule containing grapefruit extract
Administration: Take one packet (containing 10 capsules) with water within 15 minutes after meal (either breakfast, lunch, or dinner).
In total two packets (containing 20 capsules, as 80 mg or more of auraptene) a day, taken twice daily.
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Subjects aged 20 or more and less than 65
4. Healthy subjects
Key exclusion criteria
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily
5. Subjects who are currently taking medications (including herbal medicines) and supplements
6. Subjects who use the following medicines: antihypertensive agent, antianginal agent, antiarrhythmic agent, antilipemic agent, antiulcer drug, antibiotic, trematode infection medication, antineoplastic agent, anti-anxiety agent, immunosuppressive agent, antiallergic drug, adrenocortical hormone, hypnotics and sedatives, anti-HIV agent, thyroid hormone, antimalarial agent, analgesic agent, antiplatelet agent, vasopressin receptor antagonist, drug to prevent gout attacks, or antiasthmatic
7. Subjects who are allergic to medicines and/or the test food related products
8. Subjects who are pregnant, lactating, or planning to become pregnant during this trial
9. Subjects who suffer from COVID-19
10. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial
11. Subjects who are judged as ineligible to participate in this study by the physician
12. Subjects who recently changed their lifestyle
13. Subjects with an upset stomach
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
ARKRAY Group Karada Lab, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel
03-5793-3623
IRB@takara-clinic.com
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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 28 | 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
11
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
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 28 | Day |
Last modified on
| 2023 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056214
