UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022244 |
|---|---|
| Receipt number | R000025628 |
| Scientific Title | An Open-label, Uncontrolled Study on Safety of Excessive Intake of Green Tea Containing Polyphenol |
| Date of disclosure of the study information | 2016/05/09 |
| Last modified on | 2017/01/06 16:08:04 |
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Basic information
Public title
An Open-label, Uncontrolled Study on Safety of Excessive Intake of Green Tea Containing Polyphenol
Acronym
Safety of Excessive Intake of GreenTea Containing Polyphenol
Scientific Title
An Open-label, Uncontrolled Study on Safety of Excessive Intake of Green Tea Containing Polyphenol
Scientific Title:Acronym
Safety of Excessive Intake of GreenTea Containing Polyphenol
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prove the safety of the green tea containing polyphenol in case of a dose 3 times higher than its recommended daily intake for 4 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The pattern, severity and frequency of side effects related to ingestion of the active test food during the administration period and the post administration period.
Key secondary outcomes
The pattern, severity and frequency of adverse events during the administration period and the post administration period, the body composition (BW, BFP and BMI) and blood lipids (TC, LDL-C, HDL-C, TG, NEFA and phospholipid)
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Daily ingestion of 4.0 g (green tea containing 100 mg of polyphenol)x 3 packs 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Subjects who meet the following criterion either a, b or c
a. Subjects whose LDL-C is >=120 mg/dl and <160 mg/dl and BMI is >=18.5 kg/m2and <30.0 kg/m2.
b. Subjects whose LDL-C is >=70 mg/dl and <160 mg/dl and BMI is >=23.0 kg/m2 and <30.0 kg/m2.
c. Subjects whose LDL-C is >=70 mg/dl and <120 mg/dl and BMI is >=18.5 kg/m2 and <23.0 kg/m2.
2. Subjects who agree to participate in the current study with a written informed consent.
Key exclusion criteria
1.Subjects who are under physician's advice, treatment and/or medication for obesity, hyperlipidemia and diabetes.
2.Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, disorder of endocrine and metabolism or affected with infectious diseases which are required to report to the authorities.
3.Subjects who have a major surgical history related to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
4. Subjects with unusually high and/or low blood pressure or abnormal hematological data.
5. Subjects with serious anemia.
6. Pre- or post-menopausal women having obvious changes in physical condition.
7. Subjects who are at risk of having allergic reactions to drugs or foods (especially tea). 8. Subjects who have largely changed their dietary habits, physical activity habits and/or BW within the last 6 months.
9. Subjects with familial hypercholesterolemia.
10. Subjects who regularly take drugs, functional foods and/or supplements which would affect BW and BFP.
11. Subjects who regularly take drugs, functional foods and/or supplements which would affect the blood lipid levels.
12. Subjects who regularly take drugs, functional foods and/or supplements which would affect blood glucose.
13. Heavy smokers, alcohol addicts or subjects with irregular lifestyle.
14.Subjects who donated either 400ml whole blood within 12 weeks (men) /16 weeks (women) or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to this study.
15. Pregnant or lactating women or women expect to be pregnant during the clinical trial.
16. Subjects who participated in other clinical trials within the last one month prior to this study.
17. Subjects who have participated in previous clinical trials of ingestion of the same active test food.
18. Any other medical reasons judged by the principal investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Prof. Jun NISHIHIRA, M.D., Ph.D. |
Organization
Hokkaido Information University
Division name
Department of Medical Management and Informatics
Zip code
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4411
nishihira@do-johodai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Dir. Prof. Jun NISHIHIRA, M.D., Ph.D. |
Organization
Hokkaido Information University
Division name
Center of Health Information Science
Zip code
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4430
Homepage URL
nishihira@do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
Funding Source
Organization
The Ethics Committee approves that the source of funding shall not be disclosed.
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
Address
Tel
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
北海道情報大学 保健センター（北海道）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 09 | 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
| 2016 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2016 | Year | 07 | Month | 21 | Day |
Date of closure to data entry
| 2016 | Year | 08 | Month | 25 | Day |
Date trial data considered complete
| 2016 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 22 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 09 | Day |
Last modified on
| 2017 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025628
