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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025996
Receipt No. R000029884
Scientific Title A study for evaluating the effect of the intake of the test products on postprandial hyperglycemia for healthy male
Date of disclosure of the study information 2017/02/03
Last modified on 2017/05/29

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Basic information
Public title A study for evaluating the effect of the intake of the test products on postprandial hyperglycemia for healthy male
Acronym A study for evaluating the effect of the intake of the test products on postprandial hyperglycemia for healthy male
Scientific Title A study for evaluating the effect of the intake of the test products on postprandial hyperglycemia for healthy male
Scientific Title:Acronym A study for evaluating the effect of the intake of the test products on postprandial hyperglycemia for healthy male
Region
Japan

Condition
Condition Healthy male
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of the test products on postprandial hyperglycemia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incremental area under the curve of plasma glucose
Key secondary outcomes Peak in plasma glucose concentration, fasting plasma glucose , plasma glucose at 15, 30, 45, 60, 90, and 120 min.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Intake of the standard products,Intake of the test products
Interventions/Control_2
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
50 years-old >=
Gender Male
Key inclusion criteria (1)Males from 20 to 50 years of age.
(2)Subjects who have a difference of incremental area under the curve of plasma glucose levels between preliminary examination 1 and preliminary examination 2 within 25 percent.
Key exclusion criteria (1)Subjects routinely taking medicine or health food which may influence glucose metabolism.
(2)Subjects who have abnormal glucose tolerance within the one month prior on preliminary examination.
(3)Subjects who have body mass index (BMI) less than 18.5 kg per square meter or more than 25.0 kg per square meter.
(4)Subjects who have abnormal glucose tolerance on preliminary examination
(5)Subjects who work at night or have irregular life more than one time in the study.
(6)Subjects who are planning to go overseas.
(7)Subjects with allergies to the test food in the study.
(8)Subjects who drink alcohol a lot.
(9)Subjects who smoke a lot.
(10)Subjects who has serious illness such as diabetes, liver disease, kidney disease, heart disease, digestive system disease.
(11)Subjects who have a disease under medication or having a history of study such as obesity, dyslipidemia, hypertension or who has a serious disease.
(12)Subject who are judged as unsuitable for the study from clinical measurements for preliminary tests and measurements.
(13)Subjects who have participated in other clinical study within the last one month or have planned to participate other clinical studies.
(14)Subjects who are judged as unsuitable for the study from questionnaire.
(15)Subjects who are judged as ineligible by clinical investigator.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeki Satomi
Organization House Foods Co., Ltd
Division name Research & Development institute
Zip code
Address 1-4, Takanodai, Yotsukaido, Chiba
TEL 043-237-5211
Email s-satomi@housefoods.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriko Watanabe
Organization TTC Co.,Ltd.
Division name Clinical Research Planning Department
Zip code
Address 1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL 03-5459-5329
Homepage URL
Email n.watanabe@ttc-tokyo.co.jp

Sponsor
Institute TTC Co.,Ltd.
Institute
Department

Funding Source
Organization House Foods 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
2017 Year 02 Month 03 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
2017 Year 01 Month 26 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 02 Month 03 Day
Last modified on
2017 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029884

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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