UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027809 |
|---|---|
| Receipt number | R000031866 |
| Scientific Title | Safety evaluation study of excessive consumption of dietary fiber-containing green tea beverage |
| Date of disclosure of the study information | 2017/06/19 |
| Last modified on | 2019/07/08 10:51:09 |
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Basic information
Public title
Safety evaluation study of excessive consumption of dietary fiber-containing green tea beverage
Acronym
Safety evaluation study of excessive consumption of dietary fiber-containing green tea beverage
Scientific Title
Safety evaluation study of excessive consumption of dietary fiber-containing green tea beverage
Scientific Title:Acronym
Safety evaluation study of excessive consumption of dietary fiber-containing green tea beverage
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of excessive consumption of green tea beverage containing 3-fold dietary fiber of recommended daily intake.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety evaluation items: Examination by a physician in charge, Physical examination findings, Clinical laboratory findings (Hematological test, Biochemical test, Urine analysis), Subjective symptoms
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
Ingestion of 3-fold dietary fiber of recommended daily intake in test food for 4 weeks.
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Japanese adult male and female from 20 to 69 years old at the time of acquiring consent.
(2)Healthy subjects whose physical examination findings and clinical laboratory findings do not deviate greatly from the normal values at the time of screening.Or Subjects with triglyceride values from 150 - 199 mg/dL, and whose physical examination findings and clinical laboratory findings do not deviate greatly from the normal values at the time of screening.
(3)Subjects who are available at every designated hospital visit.
(4)Subjects who agree to participate in this study and can put signature and date to informed consent form by themselves prior to the study.
Key exclusion criteria
(1)Subjects with hepatic, renal, cardiac or organ disorders, diabetes, or other serious diseases.
(2)Subjects with a surgical history of digestive system (except appendicectomy).
(3)Subjects with chronic diseases under treatment.
(4)Subjects who are pregnant or lactating, or intend to become pregnant during the study.
(5)Subjects who consume excessive alcohol (equivalent to more than 540 mL/day of sake or 1,500 mL/day of 5% beer or such) for 5 days or more per week.
(6)Subjects who are aware of having weak stomach or difficulties of taking green tea beverages.
(7)Subjects who don't like caffeine
(8)Subjects who have experienced allergic reactions to foods containing green tea ingredients
(9)Subjects judged as unsuitable for the study by principal investigator for other reasons.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Takano |
Organization
Medical Corporation Hokubukai Utsukushigaoka Hospital
Division name
Clinical Pharmacology Center
Zip code
004-0839
Address
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
TEL
011-882-0111
wakimoto@ughp-cpc.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Wakimoto |
Organization
Medical Corporation Hokubukai Utsukushigaoka Hospital
Division name
Clinical Pharmacology Center
Zip code
004-0839
Address
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
TEL
011-882-0111
Homepage URL
wakimoto@ughp-cpc.jp
Sponsor or person
Institute
Medical Corporation Hokubukai Utsukushigaoka Hospital
Institute
Department
Personal name
Funding Source
Organization
Haruna Produce Co., Ltd.
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 institutional review board
Address
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
Tel
011-881-0111
wakimoto@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
医療法人北武会 美しが丘病院/Utsukushigaoka Hospital , Medical Corporation Hokubukai
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 19 | Day |
Related information
URL releasing protocol
Safety evaluation study of excessive consumption of dietary fiber-containing green tea beverage
Publication of results
Unpublished
Result
URL related to results and publications
Safety was confirmed.
Number of participants that the trial has enrolled
16
Results
Safety was confirmed.
Results date posted
| 2019 | Year | 07 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
(1)Japanese adult male and female from 20 to 69 years old at the time of acquiring consent.
(2)Healthy subjects whose physical examination findings and clinical laboratory findings do not deviate greatly from the normal values at the time of screening.Or Subjects with triglyceride values from 150 - 199 mg/dL, and whose physical examination findings and clinical laboratory findings do not deviate greatly from the normal values at the time of screening.
(3)Subjects who are available at every designated hospital visit.
(4)Subjects who agree to participate in this study and can put signature and date to informed consent form by themselves prior to the study.
Participant flow
screening
Selection
intake
Inspection
Adverse events
None
Outcome measures
Safety evaluation items: Examination by a physician in charge, Physical examination findings, Clinical laboratory findings (Hematological test, Biochemical test, Urine analysis), Subjective symptoms
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 19 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 20 | Day |
Date of closure to data entry
| 2017 | Year | 11 | Month | 06 | Day |
Date trial data considered complete
| 2017 | Year | 11 | Month | 06 | Day |
Date analysis concluded
| 2017 | Year | 11 | Month | 06 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 19 | Day |
Last modified on
| 2019 | 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=R000031866
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