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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020763
Receipt No. R000023958
Scientific Title A study on the effect of powdered tea on postprandial hyperglycemia - A randomized, double-blind, placebo-controlled, cross-over trial -
Date of disclosure of the study information 2016/01/29
Last modified on 2016/07/27

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Basic information
Public title A study on the effect of powdered tea on postprandial hyperglycemia
- A randomized, double-blind, placebo-controlled, cross-over trial -
Acronym A study on the effect of powdered tea on postprandial hyperglycemia
Scientific Title A study on the effect of powdered tea on postprandial hyperglycemia
- A randomized, double-blind, placebo-controlled, cross-over trial -
Scientific Title:Acronym A study on the effect of powdered tea on postprandial hyperglycemia
Region
Japan

Condition
Condition Healthy adult (subjects with impaired fasting glucose (fasting plasma glucose = 110-125 mg/dl) or impaired glucose tolerance (75g-OGTT 2 hour glucose = 140 - 199 mg/dl))
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of powdered tea on postprandial hyperglycemia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Postprandial plasma glucose levels
Key secondary outcomes ・Postprandial insulin levels
・Maximum concentration (Cmax) and area under the curve (AUC) of postprandial plasma glucose levels
・Cmax and AUC of postprandial insulin levels

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 Prevention
Type of intervention
Food
Interventions/Control_1 Intake of test drink (powdered tea, 200 ml) in a single dose together with high-carbohydrate meal (300 g), and then intake of placebo drink (200 ml) in a single dose together with high-carbohydrate meal (300 g) after 1-week washout period.
Interventions/Control_2 Intake of placebo (200 ml) in a single dose together with high-carbohydrate meal (300 g), and then intake of powdered tea (200 ml) in a single dose together with high-carbohydrate meal (300 g) after 1-week washout period.
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
65 years-old >
Gender Male and Female
Key inclusion criteria 1) Males and females from 20 to 64 years age
2) Subjects whose fasting plasma glucose levels are from 110 to 125 mg/dl or whose 75g-oral glucose tolerance test (OGTT) 2 hour glucose levels are from 140 to 199 mg/dl
3) Not heavy alcoholic drinker. (Subjects who can stop drinking from 2 days before each measurement.)
4) Subjects who can make self-judgment and are voluntarily giving written informed consent
Key exclusion criteria 1) Subjects who use oral medication affecting blood glucose
2) Subjects who constantly consume supplements and/or functional foods (including Food for Specified Health Uses) affecting blood glucose
3) Subjects who have declared allergic reaction to ingredients contained in powdered tea, placebo or high-carbohydrate diet
4) Subjects who need medical treatment for diabetes
5) Subjects who contract or are under treatment or are medical history for serious diseases (e.g., liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder
6) Subjects who have a chronic disease and use medicines continuously
7) Subjects who have a history of digestive disease affecting digestion and absorption
8) Subjects whose blood glucose level measured by simple analyzer is more than 150 mg/dl
9) Subjects who are judged as unsuitable for the study based on the results of blood tests by the investigator
10) Subjects who have donated over 200 ml of blood and/or blood components within the last one month prior to the current study or over 400 ml of blood and/or blood components within the last three months prior to the current study
11) Subjects who are diagnosed as anemic and not suitable for frequent collection of blood
12) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism
13) Subjects who are planning to participate in other clinical studies
14) Subjects who are planning to become pregnant after informed consent for the current study or are pregnant or lactating
15) Subjects who are judged as unsuitable for the study by the investigator for other reasons
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshitaka Iwama
Organization Nihonbashi Cardiology Clinic
Division name Director
Zip code
Address 13-4 Nihonbashi-Kodenmacho, Chuo-ku, Tokyo, Japan
TEL 03-5641-4133
Email yiwama@well-sleep.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiji Yoshikawa
Organization KSO Corporation
Division name Sales department
Zip code
Address 1-9-7 Shibaura, Minato-ku, Tokyo, Japan
TEL 03-3452-7733
Homepage URL
Email yoshikawa@kso.co.jp

Sponsor
Institute KSO Corporation
Institute
Department

Funding Source
Organization YAKULT HONSHA CO., LTD
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 29 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
2016 Year 01 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2016 Year 06 Month 06 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 01 Month 27 Day
Last modified on
2016 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023958

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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