UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000035496
Receipt No. 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 (Ver. 8)

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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
Email 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
Email masato.nishiwaki@oit.ac.jp

Sponsor
Institute Faculty of Engineering, Osaka Institute of Technology
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040445