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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name