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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021650
Receipt No. R000024885
Scientific Title Study on effects of functional fermented tea, Wonder Leaf, made from green tea leaves and loquat leaves on postprandial blood glucose levels, part2.
Date of disclosure of the study information 2016/03/28
Last modified on 2016/10/28

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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, part2.
Acronym Effects of functional tea on postprandial blood glucose levels, part2.
Scientific Title Study on effects of functional fermented tea, Wonder Leaf, made from green tea leaves and loquat leaves on postprandial blood glucose levels, part2.
Scientific Title:Acronym Effects of functional tea on postprandial blood glucose levels, part2.
Region
Japan

Condition
Condition Postprandial hyperglycemia
Classification by specialty
Endocrinology and Metabolism
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 120min)
Key secondary outcomes Body weight

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
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 (low concentration) after 7 days or 14 days.
And injested a single intake of the active meal (high concentration) after 7 days or 14 days.
Interventions/Control_2 The subjects ingested a single intake of the active meal (low concentration) , and injested a single intake of the active meal (high concentration) after 7 days or 14 days.
And injested a single intake of the placebo meal after 7 days or 14 days.
Interventions/Control_3 The subjects ingested a single intake of the active meal (high concentration) , and injested a single intake of the placebo meal after 7 days or 14 days.
And injested a single intake of the active meal (low concentration)after 7 days or 14 days.
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)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 diseases.
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 woman.
7)Individuals participating or intending to participate in a drug administration test.
8)Individuals judged by the doctor to be unsuitable.
Target sample size 52

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, Nishisosnogi-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 Kazunari Tanaka
Organization Univercity of Nagasaki
Division name Faculty of Nursing and Nutrition
Zip code
Address 1-1-1 Manabino, Nagayo-cho, Nishisosnogi-gun, Nagasaki, Japan, 851-2195
TEL 095-813-5216
Homepage URL
Email katanaka@sun.ac.jp

Sponsor
Institute Univercity of Nagasaki
Institute
Department

Funding Source
Organization Nagasaki Prefecture
Organization
Division
Category of Funding Organization Local Government
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
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 長崎県立大学(長崎県)

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 28 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
The fermented tea made from loquat leaves and green tea leaves has suppressive effect on the elevation of postprandial blood glucose levels.
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 03 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2016 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 03 Month 28 Day
Last modified on
2016 Year 10 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024885

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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