UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023967 |
|---|---|
| Receipt number | 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 | 2024/07/16 10:20:36 |
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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 | Kazunari |
| Middle name | |
| Last name | Tanaka |
Organization
Univercity of Nagasaki
Division name
Faculty of Nursing and Nutrition
Zip code
8512195
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 | Hideki |
| Middle name | |
| Last name | Ito |
Organization
Univercity of Nagasaki
Division name
Faculty of Nursing and Nutrition
Zip code
8512195
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
TEL
095-813-5500
Homepage URL
si-rinri@sun.ac.jp
Sponsor or person
Institute
Univercity of Nagasaki
Institute
Department
Personal name
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
Univercity of Nagasaki
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
Tel
0958135216
katanaka@sun.ac.jp
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
60
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
| 2016 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 31 | Day |
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
| 2024 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027590
