UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019714 |
|---|---|
| Receipt number | R000022773 |
| Scientific Title | Study on effects of functional fermented tea, Wonder Leaf, made from green tea leaves and loquat leaves on postprandial blood glucose levels |
| Date of disclosure of the study information | 2015/11/09 |
| Last modified on | 2017/03/12 14:25:40 |
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Basic information
Public title
Study on effects of functional fermented tea, Wonder Leaf, made from green tea leaves and loquat leaves on postprandial blood glucose levels
Acronym
Study on effects of functional fermented tea made from green tea leaves and loquat leaves on postprandial blood glucose levels
Scientific Title
Study on effects of functional fermented tea, Wonder Leaf, made from green tea leaves and loquat leaves on postprandial blood glucose levels
Scientific Title:Acronym
Study on effects of functional fermented tea made from green tea leaves and loquat leaves on postprandial blood glucose levels
Region
| Japan |
Condition
Condition
Postprandial hyperglycemia
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of a fermented tea on postprandial hyperglycemia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postprandial blood glucose (0, 30, 60 and 120 min)
Key secondary outcomes
Blood pressure, Body weight, BMI
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
The subjects ingested a single intake of the placebo meal, and injested a single intake of the active meal after 7 days or 14 days.
Interventions/Control_2
The subjects ingested a single intake of the active meal, and injested a single intake of the placebo meal after 7 days or 14 days.
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
| 83 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Aged more than 20
2) Fasting blood glucose > 82, and < 144 mg/dl
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 glucose level.
2) Subjects who are contracting kidney and/or liver diseases.
3) Individuals judged to have diabetes mellitus.
4) Individuals with a chronic disease.
5) Person who donated more than 400 ml of blood within 3 months prior to the study.
6) Pregnant women, or women with intending to become pregnant, and lactating women.
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
| 1st name | |
| Middle name | |
| Last name | Kazunari TANAKA |
Organization
University 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
katanaka@sun.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Ito |
Organization
University 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
katanaka@sun.ac.jp
Sponsor or person
Institute
University of Nagasaki
Institute
Department
Personal name
Funding Source
Organization
University of Nagasaki
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nagasaki Prefecture
Name of secondary funder(s)
Nagasaki Prefecture
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
長崎県立大学（長崎県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 09 | 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
| 2015 | Year | 10 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 09 | Day |
Last modified on
| 2017 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022773
