UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on effects of functional mixed fermented tea leaf powder made from unripe orange fruits and green tea leaves on blood pressure.
Title of the study (Brief title)	Study on effects of fermented tea leaf powder made from unripe orange fruits and green tea leaves on blood pressure.
Region	Japan

Condition
Condition	high blood pressure
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

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

Assessment
Primary outcomes	blood pressure
Key secondary outcomes	Body weight, Visceral fat area, Waist length, Blood pressure, Serum cholesterol, Serum triglyceride, Blood glucose level, Gamma-GTP, White blood cell count, Red blood cell count, hemoglobin, Hematocrit, Platelet count, Total Bilirubin, Total protein, Albumin, Urea nitrogen, Creatinine, uric acid,Renin, angiotensin converting enzyme

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	The subjects ingested the placebo meal for twelve weeks.
Interventions/Control_2	The subjects ingested the active meal(low concentration) for twelve weeks.
Interventions/Control_3	The subjects ingested the active meal(high concentration) for twelve weeks.
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 between 20 and 70 years old 2)Individuals whose systolic blood pressure is 130 or more and 159 or less, or diastolic blood pressure is 85 or more and 99 or less 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 blood pressure 2)Those who can not stop taking supplements or health foods that may affect blood pressure during the test period 3)Subjects who are contracting kidney and/or liver diseases 4)Those who have been diagnosed with Familial hypertension 5)Individuals with a chronic diseases 6)Person who donated more than 400 ml of blood within 3 months prior to the study 7)Those who can not stop taking a large amount of green tea or black tea during the test period 8)Pregnant women, or women with intending to become pregnant, and lactating woman 9)Individuals participating or intending to participate in a drug administration test 10)Individuals judged by the doctor to be unsuitable
Target sample size	60

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	Regional Collaboration Center
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	2018 Year 06 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 05 Month 31 Day
Anticipated trial start date	2018 Year 06 Month 01 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	2018 Year 05 Month 23 Day
Last modified on	2018 Year 12 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036925