UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032682 |
|---|---|
| Receipt number | R000036925 |
| Scientific Title | Study on effects of functional mixed fermented tea leaf powder made from unripe orange fruits and green tea leaves on blood pressure. |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2018/12/17 10:35:49 |
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Basic information
Public title
Study on effects of functional mixed fermented tea leaf powder made from unripe orange fruits and green tea leaves on blood pressure.
Acronym
Study on effects of fermented tea leaf powder made from unripe orange fruits and green tea leaves on blood pressure.
Scientific Title
Study on effects of functional mixed fermented tea leaf powder made from unripe orange fruits and green tea leaves on blood pressure.
Scientific Title:Acronym
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
| 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
katanaka@sun.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Ito |
Organization
Univercity of Nagasaki
Division name
Regional Collaboration Center
Zip code
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
TEL
095-813-5500
Homepage URL
katanaka@sun.ac.jp
Sponsor or person
Institute
Univercity of Nagasaki
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 31 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036925
