UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048998 |
|---|---|
| Receipt number | R000055819 |
| Scientific Title | Safety evaluation of a single intake of a test food containing Plant extract- an open-label, single arm study |
| Date of disclosure of the study information | 2023/09/15 |
| Last modified on | 2023/05/16 11:53:52 |
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Basic information
Public title
Safety evaluation of a single intake of a test food containing Plant extract
Acronym
Safety evaluation of a single intake of a test food containing Plant extract
Scientific Title
Safety evaluation of a single intake of a test food containing Plant extract-
an open-label, single arm study
Scientific Title:Acronym
Safety evaluation of a single intake of a test food containing Plant extract
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of single intake of foods containing Plant extract, at recommended daily dose as well as triple and quintuple doses
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Subjective symptoms, physician's examination findings, physical examination, clinical examination
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
NO
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 recommended daily dosage of test food containing Plant extract followed by single intake of its 3 times ,then aingle intake of its 5 times with 6 days or more intervals.
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 males and females aged 20- and 65 at the time of informed consent
2. Subjects who can be available to the study site on the visiting dates
3. Subjects who consented to participate in the study prior to the start of the study and be able to sign and date the consent document by themselves.
Key exclusion criteria
1. Subjects with a serious medical history and those suffering from hepatic disorder, renal or cardiac disease, organ failure, diabetes mellitus, or other serious diseases
2. Subjects with a history of gastrointestinal resection (except for appendicectomy)
3. Subjects with chronic diseases under treatment
4. Subjects who are at risk of developing an allergy in relation to the study
5. Subjects who are aware that the frequency of defecation or stool characteristics may easily change significantly as gastrointestinal symptoms.
6. Heavy drinkers of alcohol (>60 g/day of pure alcohol) or excessive smokers (>20 cigarettes/day) or smokers who cannot quit smoking during the study under unified control.
7. Pregnant or planning to become pregnant or breastfeeding during the study period
8. Subjects who work late at night, work overtime for a long period of time, or work the irregular shifts
9. Subjects who are participating in other study in which test foods or drugs are taken, or in which cosmetics or drugs are applied, or who plan to participate in other study during the study period.
10. Subjects who may need to avoid consuming the food or beverage used in the study with religious or other reasons, since the origin of the ingredients are not specified.
11. Those who are judged to be unsuitable as subjects based on the results of the background survey.
12. Subjects whose physical or clinical examination data prior to the start of intake are significantly out of the reference range.
13. Subjects who are judged to be inappropriate to participate in this study by the investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Sayuri |
| Middle name | |
| Last name | Matsuoka |
Organization
FANCL Corporation
Division name
FANCL Research Institute
Zip code
2440806
Address
12-13 Kamishinano, Totsuka, Yokohama, Kanagawa, 244-0806, Japan
TEL
045-820-3755
matsuoka@fancl.co.jp
Public contact
Name of contact person
| 1st name | Isao |
| Middle name | |
| Last name | Takehara |
Organization
Clinical Support Corporation, Ltd.
Division name
Food Service Division
Zip code
060-0061
Address
4-1 South 1 West 8, Chuo-ku, Sapporo, Hokkaido, 060-0061, Japan
TEL
011-223-3130
Homepage URL
takehara@csc-smo.co.jp
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation Hokubukai Utsukushigaoka Hospital Ethical Review Board
Address
61-1 Shinei, Kiyota-ku, Sapporo, Hokkaido, 004-0839, Japan
Tel
011-882-0111
matsuda@ughp-cpc.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
社会医療法人大成会 福岡記念PET・健診センター(福岡県)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | 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
10
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 | 09 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | 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 | 09 | Month | 22 | Day |
Last modified on
| 2023 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055819
