UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034773 |
|---|---|
| Receipt number | 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 18:21:04 |
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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
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
fish0510@gmail.com
Sponsor or person
Institute
University of Taipei
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039657
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
