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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034773
Receipt No. R000039657
Scientific Title Effects of exercise training and green tea extract (GTE) supplementation on exercise adaptations in healthy individuals
Date of disclosure of the study information 2018/11/05
Last modified on 2021/05/09

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Basic information
Public title Effects of exercise training and green tea extract (GTE) supplementation on exercise adaptations in healthy individuals
Acronym Exercise training and GTE supplementation on exercise adaptations
Scientific Title Effects of exercise training and green tea extract (GTE) supplementation on exercise adaptations in healthy individuals
Scientific Title:Acronym Exercise training and GTE supplementation on exercise adaptations
Region
Asia(except Japan)

Condition
Condition Healthy individuals
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of an six-week GTE supplementation and exercise training can improve training adaptions in healthy individuals
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Body composition, exercise performance, cognitive performance
Key secondary outcomes Blood biochemical parameters

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Exercise training
Interventions/Control_2 GTE supplementation
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
35 years-old >=
Gender Male and Female
Key inclusion criteria Subjects who have no serious skeletal nerve injury or surgical history or history of lower limb injury within 3 months.
Key exclusion criteria 1. Subjects who have mental illness, diabetes,cardiovascular disease (eg high blood pressure, heart disease, stroke, etc.).

2. Subjects who have acute discomfort or infections.

3. Subjects who are unable to routinely participate scheduled training program or judged as unsuitable for this study by the principal investigator or subinvestigators.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Chung-Yu
Middle name
Last name Chen
Organization University of Taipei
Division name Department of Exercise and Health Sciences
Zip code 111
Address No.101, Sec. 2, Zhongcheng Rd., Shilin Dist., Taipei City.
TEL +886228718288
Email fish0510@gmail.com

Public contact
Name of contact person
1st name Chung-Yu
Middle name
Last name Chen
Organization University of Taipei
Division name Department of Exercise and Health Sciences
Zip code 111
Address No.101, Sec. 2, Zhongcheng Rd., Shilin Dist., Taipei City.
TEL +886228718288
Homepage URL
Email fish0510@gmail.com

Sponsor
Institute University of Taipei
Institute
Department

Funding Source
Organization MOST and University of Taipei
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization University of Taipei
Address No.101, Sec. 2, Zhongcheng Rd., Shilin Dist., Taipei City.
Tel +886228718288 #7811
Email irb-iacuc@utaipei.edu.tw

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
2018 Year 11 Month 05 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039657
Publication of results Unpublished

Result
URL related to results and publications Unpublished
Number of participants that the trial has enrolled 16
Results The six-week exercise training intervention significantly increased the maximum oxygen uptake in both groups. In terms of body composition, there were no significant differences between the two groups after the experimental intervention. The GTE group showed markedly improvement in attention and substantially better maintain effect after exercise challenge.
Results date posted
2021 Year 05 Month 09 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 12 female and 4 male participants were recruited in this study. The average of age was 22.8 years old, body weight was 58.5 kg and maximal oxygen consumption was 35.5 ml/kg/min.
Participant flow 16
Adverse events There were no adverse events.
Outcome measures Body composition, exercise performance, cognitive performance, blood biochemical parameters
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 09 Month 05 Day
Date of IRB
2018 Year 09 Month 05 Day
Anticipated trial start date
2018 Year 09 Month 05 Day
Last follow-up date
2018 Year 11 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 05 Day
Last modified on
2021 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039657

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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