UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000039657