UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized double-blind study for the effect of kosen-cha on obese subjects
Title of the study (Brief title)	Randomized double-blind study for the effect of kosen-cha on obese subjects
Region	Japan

Condition
Condition	Healthy volunteers with obesity
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose is to determine whether kosen-cha improves obesity
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Body weight, body mass index, waist circumstance, visceral fat area after drinking kosen-cha for 6 or 12 weeks
Key secondary outcomes	Blood pressure, pulse rate, Hematological and biochemical evaluation by blood examination, bioactive molecules after drinking kosen-cha for 6 or 12 weeks

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	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Kosen-cha 5g tea leaf/1L/day, 12 weeks
Interventions/Control_2	Placebo 5g tea leaf/1L/day, 12 weeks
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	The healthy volunteers with obesity (BMI 25-30)
Key exclusion criteria	1. Subjects who are under pharmacological therapy 2. Subjects with chronic diseases 3. Pregnancy and nursing 4. Subjects who participate in other clinical trials at the time of this study entry 5. Smoking 6. Subjects who are drinking catechin-riched drink 7. Cancer 8. Serious liver diseases 9. High serum creatine 10. etc
Target sample size	60

Research contact person
Name of lead principal investigator	Tatsuya Morimoto
Organization	University of Shizuoka
Division name	Division of Molecular Medicine, School of Pharmaceutical Sciences
Address	52-1, Yada, Suruga-ku, Shizuoka, Shizuoka, Japan
TEL	054-264-5763
Email	morimoto@u-shizuoka-ken.ac.jp

Public contact
Name of contact person	Yasufumi Katanasaka
Organization	University of Shizuoka
Division name	Division of Molecular Medicine, School of Pharmaceutical Sciences
Address	52-1, Yada, Suruga-ku, Shizuoka, Shizuoka, Japan
TEL	054-264-5766
Homepage URL
Email	Kosencha.test@gmail.com

Sponsor
Institute	University of Shizuoka
Institute
Department

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

Other related organizations
Co-sponsor	SBS Shizuoka Health Promotion Center
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	2015 Year 12 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 07 Day
Anticipated trial start date	2015 Year 11 Month 25 Day
Last follow-up date	2016 Year 05 Month 31 Day
Date of closure to data entry	2016 Year 06 Month 30 Day
Date trial data considered complete	2016 Year 07 Month 20 Day
Date analysis concluded	2016 Year 09 Month 01 Day

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

Management information
Registered date	2015 Year 12 Month 04 Day
Last modified on	2019 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023183