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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033442
Receipt No. R000038139
Scientific Title A study to investigate Postprandial blood glucose level increase suppressing effect of study food ingestion
Date of disclosure of the study information 2018/07/20
Last modified on 2018/07/19

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Basic information
Public title A study to investigate Postprandial blood glucose level increase suppressing effect of study food ingestion
Acronym A study to investigate Postprandial blood glucose level increase suppressing effect of study food ingestion
Scientific Title A study to investigate Postprandial blood glucose level increase suppressing effect of study food ingestion
Scientific Title:Acronym A study to investigate Postprandial blood glucose level increase suppressing effect of study food ingestion
Region
Japan

Condition
Condition None
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to assess the
effect of single ingestion of tea polyphenols-containing beverage on postprandial blood glucose level by performing the comparison suing cross-over study
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Postprandial blood glucose level (AUC,C-Max)
Key secondary outcomes Awareness questionnaire

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 No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Ingestion of study food substance (Once)
Ingestion of control food substance (Once)
Interventions/Control_2 Ingestion of control food substance (Once)
Ingestion of study food substance (Once)
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)Subjects who is healthy adults of both sexes above 20 years old- under 65 years old
2)Subjects with fasting blood glucose level under 125mg/dL, and under 199mg/dL after food load at the point of screening
3)Subjects who give consent in writing with full understanding
Key exclusion criteria 1)Subjects who has difficulties to participate this study due to hepatic, kidney, cardiac disorders, lung disorder, digestive system disorder, blood disorder, endocrine disorder, metabolic defect and other serious disorders.
2)Subjects who suffer from diseases/ disorders with continuous medical treatment or with medical history of severe diseases/ disorders needed medical treatment
3)Subjects who suffer from diseases/ disorders that affects the study and are receiving medical treatment from medical institution or have surgical history of digestive system ( except appendectomy)
4)Subjects with history of sensitivity to the ingredients of test food
5)Pregnant, lactating women or willing to be pregnancy during the study
6)Subjects who had participated in other clinical trials including drug and food within 1 month.
7)Any candidates considered to be unsuitable for enrollment in the opinion of the principal investigator
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Wei Na
Organization Tasly Japan Co.,Ltd.
Division name Planning Department
Zip code
Address 3-5-7 ariake,Kouto-ku ,Tokyo,Japan
TEL 03-3529-0101
Email nai@tasly.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigeru Imai
Organization CROee.INC
Division name Evidence Division
Zip code
Address 2F YS Build. 1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
TEL 03-5953-2108
Homepage URL
Email imai@croee.com

Sponsor
Institute CROee.INC
Institute
Department

Funding Source
Organization Tasly Japan 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 東京センタークリニック(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 20 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 Preinitiation
Date of protocol fixation
2018 Year 07 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 08 Day
Last follow-up date
2018 Year 08 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 07 Month 19 Day
Last modified on
2018 Year 07 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038139

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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