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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000023967
Receipt No. R000027590
Scientific Title Study on effects of long-tern ingestion of mixed fermented tea made from unripe orange fruits and green tea leaves on body fat and vascular index.
Date of disclosure of the study information 2016/09/10
Last modified on 2017/03/12

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Basic information
Public title Study on effects of long-tern ingestion of mixed fermented tea made from unripe orange fruits and green tea leaves on body fat and vascular index.
Acronym Effects of mixed fermented tea made from unripe orange fruits and green tea leaves on body fat and vascular index.
Scientific Title Study on effects of long-tern ingestion of mixed fermented tea made from unripe orange fruits and green tea leaves on body fat and vascular index.
Scientific Title:Acronym Effects of mixed fermented tea made from unripe orange fruits and green tea leaves on body fat and vascular index.
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 mixed fermented tea made from unripe orange fruits and green tea leaves on improving the blood vessel elasticity.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Vascular index
Key secondary outcomes Body weight,Visceral fat area,Waist length,BMI,Blood pressure

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 Intake a placebo food for 8weeks.
Interventions/Control_2 Intake a active food for 8weeks.
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) Aged more than 20
2) Individuals who can refrain from gluttony during the test period
3) 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 and blood pressure.
2)Subjects who are contracting diabetes,kidney and/or liver diseases.
3)Individuals judged to have Familial hypertension.
4)Individuals with a chronic diseases.
5)Pregnant women,or women with intending to become pregnant,and lactating woman.
6)Individuals who is unable to stop high intakes of green tea, black tea during the test period.
7)Individuals participating or intending to participate in a drug administration test.
8)Individuals judged by the doctor to be unsuitable.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazunari Tanaka
Organization Univercity of Nagasaki
Division name Faculty of Nursing and Nutrition
Zip code
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
1st name
Middle name
Last name Hideki Ito
Organization Univercity of Nagasaki
Division name Faculty of Nursing and Nutrition
Zip code
Address 1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
TEL 095-813-5500
Homepage URL
Email si-rinri@sun.ac.jp

Sponsor
Institute Univercity of Nagasaki
Institute
Department

Funding Source
Organization Nagasaki Prefecture
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 09 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2016 Year 09 Month 10 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2017 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 09 Month 07 Day
Last modified on
2017 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027590

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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