UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on effects of long-tern ingestion of fermented tea leaf powder "Marugoto Hakkocha" made from green tea leaves and loquat leaves on body fat.
Title of the study (Brief title)	Effects of fermented tea leaf powder on body fat.
Region	Japan

Condition
Condition	obesity
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of long-tern ingestion fermented tea leaf powder on suppression of body fat.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visceral fat area
Key secondary outcomes	Body weight,Body fat percentage,BMI,Waist length,Blood pressure,Serum cholesterol,Serum triglyceride,Blood glucose level,GOT,GPT,Gamma-GTP,White blood cell count,Red blood cell count,hemoglobin,Hematocrit,Platelet count,LD,Total Bilirubin,ALP,HbA1c,Total protein,Albumin,Urea nitrogen,Creatinine,uric acid,questionnaire

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	Prevention
Type of intervention	Food
Interventions/Control_1	The subjects ingested the active meal for eight weeks.
Interventions/Control_2	The subjects ingested the placebo meal for eight 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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Healthy male and female aged 20 to 70 2) Individuals whose visceral fat area is approximately 60 cm2 or more and BMI is 23 to 30 3) Individuals who can refrain from drinking and eating during the test period 4) Individuals who understand the purpose and contents of the experiment
Key exclusion criteria	1)Individuals taking drugs, supplements and healthy foods which affect the lipid metabolism. 2)Subjects who are contracting diabetes,kidney and/or liver diseases. 3)Individuals who have been diagnosed with familial hyperlipemia. 4)Individuals with a chronic diseases. 5)Individuals who can not stop taking a large amount of green tea or black tea during the examination period 6)Pregnant women,or women with intending to become pregnant,and lactating woman. 7)Individuals participating or intending to participate in a drug administration test. 8)Individuals judged by the doctor to be unsuitable.
Target sample size	50

Research contact person
Name of lead principal investigator	Kazunari Tanaka
Organization	Univercity of Nagasaki
Division name	Faculty of Nursing and Nutrition
Address	1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
TEL	095-813-5216
Email	katanaka@sun.ac.jp

Public contact
Name of contact person	Hideki Ito
Organization	Univercity of Nagasaki
Division name	Faculty of Nursing and Nutrition
Address	1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
TEL	095-813-5500
Homepage URL
Email	katanaka@sun.ac.jp

Sponsor
Institute	Univercity of Nagasaki
Institute
Department

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

Other related organizations
Co-sponsor
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 07 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 01 Day
Anticipated trial start date	2017 Year 06 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 12 Month 16 Day

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

Management information
Registered date	2017 Year 07 Month 04 Day
Last modified on	2018 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031836