UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on effects of functional fermented tea, Wonder Leaf, made from green tea leaves and loquat leaves on postprandial blood glucose levels
Title of the study (Brief title)	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	Kazunari TANAKA
Organization	University of Nagasaki
Division name	Faculty of Nursing and Nutrition
Address	1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
TEL	095-813-5500
Email	katanaka@sun.ac.jp

Public contact
Name of contact person	Hideki Ito
Organization	University of Nagasaki
Division name	Faculty of Nursing and Nutrition
Address	1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
TEL	095-813-5500
Homepage URL
Email	katanaka@sun.ac.jp

Sponsor
Institute	University of Nagasaki
Institute
Department

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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022773