UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035496 |
|---|---|
| Receipt number | R000040445 |
| Scientific Title | The effect of regular green tea ingestion on arterial stiffness and metabolic responses in exercise. |
| Date of disclosure of the study information | 2019/05/01 |
| Last modified on | 2020/07/24 14:40:37 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effect of regular green tea ingestion on arterial stiffness and metabolic responses in exercise.
Acronym
The effect of green tea.
Scientific Title
The effect of regular green tea ingestion on arterial stiffness and metabolic responses in exercise.
Scientific Title:Acronym
The effect of green tea.
Region
| Japan |
Condition
Condition
Healthy young adult population
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of regular green tea ingestion on arterial stiffness and metabolic responses in exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Arterial stiffness (after 4 week)
Key secondary outcomes
Respiratory gas responses in exercise (a fter 4 week)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Control-Bottled water ingestion (500 ml/day), 4 week
Interventions/Control_2
Intervention 1-Green tea ingestion (500 ml/day), 4 week
Interventions/Control_3
Intervention 2-Strong green tea ingestion (500 ml/day), 4 week
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
18 years and older men and women, no t restricted by a doctor from exercising, not have medication and smoking.
Key exclusion criteria
Have a cardiovascular and cerebrovasc ular disease.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Nishiwaki |
Organization
Osaka Institute of Technology
Division name
Faculty of Engineering
Zip code
535-8585
Address
5-16-1 Ohmiya, Asahi-ku, Osaka
TEL
06-6954-4391
masato.nishiwaki@oit.ac.jp
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Nishiwaki |
Organization
Osaka Institute of Technology
Division name
Faculty of Engineering
Zip code
535-8585
Address
5-16-1 Ohmiya, Asahi-ku, Osaka
TEL
06-6954-4391
Homepage URL
masato.nishiwaki@oit.ac.jp
Sponsor or person
Institute
Faculty of Engineering, Osaka Institute of Technology
Institute
Department
Personal name
Funding Source
Organization
Faculty of Engineering, Osaka Institute of Technology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Human Ethics Committee at the Osaka Institute of Technology
Address
5-16-1 Ohmiya, Asahi-ku, Osaka
Tel
06-6954-4163
OIT.Tbu@josho.ac.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
| 2019 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/jspfsm/69/3/69_249/_pdf/-char/ja
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jspfsm/69/3/69_249/_pdf/-char/ja
Number of participants that the trial has enrolled
57
Results
Arterial stiffness and metabolic responses during exercise did not change before and after four weeks intervention.
Results date posted
| 2020 | Year | 03 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 06 | Month | 01 | Day |
Baseline Characteristics
Japanese healthy college students
Participant flow
41 Excluded (refused to participate and did not meet inclusion criteria) and 57 randomly assigned.
Adverse events
Nothing
Outcome measures
weight, body fat, arterial stiffness
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 10 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 09 | Day |
Last modified on
| 2020 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040445
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
