UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044208 |
|---|---|
| Receipt number | R000050477 |
| Scientific Title | Safety evaluation of long term intake of test supplement |
| Date of disclosure of the study information | 2021/05/16 |
| Last modified on | 2023/11/14 09:16:46 |
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Basic information
Public title
Safety evaluation of long term intake of test supplement
Acronym
Safety evaluation of long term intake of test supplement
Scientific Title
Safety evaluation of long term intake of test supplement
Scientific Title:Acronym
Safety evaluation of long term intake of test supplement
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the safety of ingestion of test supplement containing plant extract for 12 consecutive weeks, using placebo as a control.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Hematologic test
Blood biochemistry test
Urine analysis
Blood pressure/pulsation
Body weight/body mass index
Doctor's question
Adverse event
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test supplement for 12 consecutive weeks
Interventions/Control_2
Intake of placebo for 12 consecutive weeks
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
Male and female whose age is between 20 and 64 years old.
Key exclusion criteria
1. Subjects who are judged as unsuitable for the study based on the results of clinical laboratory test or cardiopulmonary function.
2. Subjects who have allergy related to this study.
3. Subjects who have diseases requiring continuous medication, or serious medical history who needed medication.
4. Subjects whose clinical laboratory tests, blood pressure, and physical measurements before intake of trial supplements are significantly out of the standard values.
5. Subjects who have participated in other clinical studies.
6. Females who are known or suspected to be pregnant, breastfeeding or desire to become pregnant during the trial period.
7. Subjects who are judged as unsuitable for the study based on the answers of background survey.
8. Subjects who are judged as unsuitable for the study by the investigator for other reasons.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Yui |
Organization
FANCL Corporation
Division name
12-13 Kamishinano, Totsuka-ku, Yokohama, Kanagawa
Zip code
244-0806
Address
12-13 Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3755
ke-yui@fancl.co.jp
Public contact
Name of contact person
| 1st name | Saki |
| Middle name | |
| Last name | Miyayama |
Organization
EP Mediate Co., Ltd.
Division name
Development Business Headquarters, TTC Center, Trial Planning Department
Zip code
162-0822
Address
Tsuruya Bldg., 2-23 Shimomiyabi-cho, Shinjuku-ku, Tokyo
TEL
03-5657-4983
Homepage URL
miyayama392@eps.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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguroku, Tokyo
Tel
080-2290-2544
makabe295@eps.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
医療法人社団幸和会 幸和クリニック
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 16 | 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
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 17 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 14 | Day |
Last modified on
| 2023 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050477
