UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of green tea and black tea extracts-containing dietary supplement intake on motor function : a randomized double-blind, parallel-group, placebo-controlled study
Title of the study (Brief title)	Effects of green tea and black tea extracts-containing dietary supplement intake on motor function
Region	Japan

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

Objectives
Narrative objectives1	Verify the influence of dietary supplement intake on motor function
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	VAS (fatigue item, degree of fatigue recovery after exercise, etc.)
Key secondary outcomes	Lactic acid,red blood cell count,MCV,CK, Inflammatory cytokines (IL-1beta, IL-6), Salivary cortisol

Base
Study type	Interventional

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

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	12-week continuous intake of green tea and black tea extracts-containing dietary supplement(low dose)
Interventions/Control_2	12-week continuous intake of green tea and black tea extracts-containing dietary supplement (high dose)
Interventions/Control_3	12-week continuous intake of placebo
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	30 years-old <=
Age-upper limit	59 years-old >=
Gender	Male and Female
Key inclusion criteria	(1)30<=Age=<59 of healthy men and women
Key exclusion criteria	(1) Subjects with diabetes, liver disease, kidney disease, gastrointestinal disease, peripheral vascular disease, or medical history for severe diseases (2) Subjects who are likely to have allergic symptoms due to components contained in the test food (3) Subjects who indicate disorder of heart and lung function (4) Subjects who indicate abnormal parameter in liver or kidney function (5) Subjects who had a gastrointestinal surgery (6) Subjects with a disease under treatment now (7) Subjects with drug or food allergy (8) Subjects who play high intensity sports or are on a diet (9) Subjects who are taking medication or functional foods which might affect the results of this study, such as medicine, quasi drug and health foods (10) Subject who consume exscessive alcohol (11) Smoker. (12) Subject who has been pregnant or subject who have a plan to become pregnant or breast feed during the study period (13) Subjects who is participating in the other study or plannning to participate during the study period (14) Subjects who isdeemed unsuitable by the principal investigator
Target sample size	60

Research contact person
Name of lead principal investigator	Koji Wakame
Organization	Hokkaido Pharmaceutical University School of Pharmacy
Division name	Pharmacology
Address	Maeda,Teine-ku,Sapporo,Hokkaido,006-8590
TEL	011-676-8682
Email	wakame-k@hokuytakudai.ac.jp

Public contact
Name of contact person	Makoto Terashima
Organization	Oneness support Co., Ltd.
Division name	Clinical trial Division
Address	Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL	06-4801-8917
Homepage URL
Email	mterashima@oneness-sup.co.jp

Sponsor
Institute	Miura Clinic, Medical Corporation Kanonkai
Institute
Department

Funding Source
Organization	WAKASA SEIKATSU Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	National Institute of Fitness and Sports in Kanoya
Name of secondary funｄer(s)

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	2017 Year 02 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 06 Day
Anticipated trial start date	2017 Year 02 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 02 Month 24 Day
Last modified on	2018 Year 07 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030194