UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025996 |
|---|---|
| Receipt number | 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 09:15:30 |
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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
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
n.watanabe@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co.,Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029884
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
