UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042646 |
|---|---|
| Receipt number | R000048664 |
| Scientific Title | Safety evaluation of excessive intake of food containing plant extract for healthy adults. |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2021/07/08 09:25:43 |
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Basic information
Public title
Safety evaluation of excessive intake of food containing plant extract for healthy adults.
Acronym
Safety evaluation of excessive intake of food containing plant extract.
Scientific Title
Safety evaluation of excessive intake of food containing plant extract for healthy adults.
Scientific Title:Acronym
Safety evaluation of excessive intake of food containing plant extract.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of excessive intake of food containing plant extract, ingest recommended daily intake (2.25 g) or 2-fold of recommended daily intake or 3-fold of recommended daily intake, for 4 weeks.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hematologic test
Blood biochemistry test
Urine analysis
Blood pressure/pulsation
Weight/BMI
Doctor's questions
Adverse event
Stool output, defecation frequency, defecation days, fecal condition
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of food containing plant extract, recommended daily intake, for 4 weeks
Interventions/Control_2
Intake of food containing plant extract, 2-fold of recommended daily intake, for 4 weeks
Interventions/Control_3
Intake of food containing plant extract, 3-fold of recommended daily intake, for 4 weeks
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy males and females from 20 to 64 years of age
Key exclusion criteria
(1) Subjects who constantly use health food or medicine richly containing involvement ingredient
(2) Subjects routinely taking medicine or health food which may influence bowel movement.
(3) Subjects having a large amount of foods which may influence bowel movement such as food containing dietary fiber and lactic acid bacteria.
(4) Subjects visiting the hospital for diseases related bowel movements and using drugs, or using commercial laxative.
(5) Subjects having diseases or a history of drug addiction or alcoholism.
(6) Subjects who are under treatment or have a history of serious disease (e.g., diabetes, liver disease, kidney disease, or heart disease).
(7) Subjects having possibilities for emerging allergy related to the study.
(8) Subjects who are under medication or having a history of serious diseases for which medication was required.
(9) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination.
(10) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study.
(11) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating.
(12) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire.
(13) Subjects 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 | Satoshi |
| Middle name | |
| Last name | Okamoto |
Organization
Sumitomo Chemical Co., Ltd.
Division name
Research Planning and Coordination Dept
Zip code
104-8260
Address
27-1, Shinkawa 2-chome, Chuo-ku, Tokyo Japan
TEL
03-5543-5271
okamotos3@sc.sumitomo-chem.co.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Yamamichi |
Organization
TTC Co., Ltd.
Division name
Clinical Research Planning Department
Zip code
162-0822
Address
Tsuruya Bldg., 2-23 Shimomiyabicho, Shinjuku-ku, Tokyo, Japan
TEL
03-5657-4983
Homepage URL
yamamichi578@eps.co.jp
Sponsor or person
Institute
TTC Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Sumitomo Chemical Co., Ltd.
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
03-6455-0880
saito876@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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | 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
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
| 2020 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 04 | Day |
Last modified on
| 2021 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048664
