UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055531 |
|---|---|
| Receipt number | R000063439 |
| Scientific Title | A clinical trial to evaluate the safety of single ingestion in overdose (five times recommended dose) of functional food ingredient. |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2024/11/12 11:45:30 |
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Basic information
Public title
A clinical trial to evaluate the safety of single ingestion in overdose (five times recommended dose) of functional food ingredient.
Acronym
A clinical trial to evaluate the safety of single ingestion in overdose (five times recommended dose) of functional food ingredient.
Scientific Title
A clinical trial to evaluate the safety of single ingestion in overdose (five times recommended dose) of functional food ingredient.
Scientific Title:Acronym
A clinical trial to evaluate the safety of single ingestion in overdose (five times recommended dose) of functional food ingredient.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of single ingestion in overdose (five times recommended dose) of lemon myrtle extract.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse events, medical interview, clinical laboratory tests (hematology test, blood biochemistry test, urine test) and physical examination (blood pressure, heart rate)
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
Single intake of the test food containing five times recommended dose of lemon myrtle extract.
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
| 49 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy males aged 20-49 years
Key exclusion criteria
(1) Subjects who are judged as unsuitable for this study in lifestyle habits (e.g., extremely unbalanced or fluctuating diet, irregular meal times, heavy alcohol consumption (average daily consumption of 20 g or more of pure alcohol), night work, day/night shift work, irregular days off, etc.)
(2) Subjects who are heavy smokers (more than 21 cigarettes a day)
(3) Subjects who are taking medication
(4) Subjects who have a disease under treatment
(5) Subjects with a history or current history of serious diseases of sugar metabolism, lipid metabolism, liver function, renal function, heart, circulatory system, respiratory system, endocrine system, immune system, or nervous system
(6) Subjects with frequent symptoms of diarrhea
(7) Subjects who are judged as unsuitable for this study based on the clinical examination and blood pressure measurement in screening test
(8) Subjects who participated in any other clinical trial (any clinical study using cosmetics, foods, drugs, quasi-drugs, medical devices, etc.) in 8 weeks or have plan to participate in any other clinical trial during this study
(9) Subjects with food allergies
(10) Subjects who are judged as unsuitable for this study by investigators in othe reasons.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Sumio |
| Middle name | |
| Last name | Kondo |
Organization
Medicial Corporation Kenshokai Fukushima Healthcare Center
Division name
Director
Zip code
553-0004
Address
Tamagawa 2-12-16, Fukushima-ku, Osaka, 553-0004, Japan
TEL
06-6441-6848
drc_shokuhin@drc-web.co.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Furusyo |
Organization
DRC Co., Ltd
Division name
Testing Department, Cosmetics and Food Effectiviness Testing Group
Zip code
530-0044
Address
No.9 Tabuchi Bldg.3F, Higashitenma 2-10-31, Kita-Ku, Osaka
TEL
06-6882-1130
Homepage URL
furusyo@drc-web.co.jp
Sponsor or person
Institute
DRC Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
KANEKA CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Brain Care Clinic Ethics Review Committee
Address
Hakutyo Build. 2F, 2-1-2 Shinjuku,Shinjuku-ku,Tokyo
Tel
03-4405-1899
ethics_board@drc-web.co.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
| 2025 | Year | 04 | Month | 01 | 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
| 2024 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 10 | 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 | 09 | Month | 18 | Day |
Last modified on
| 2024 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063439
