UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020807 |
|---|---|
| Receipt number | R000024021 |
| Scientific Title | Sucrose tolerance test for human after intake of yogurt with blood glucose elevation inhibitory effect |
| Date of disclosure of the study information | 2016/01/31 |
| Last modified on | 2017/01/05 14:47:31 |
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Basic information
Public title
Sucrose tolerance test for human after intake of yogurt with blood glucose elevation inhibitory effect
Acronym
Sucrose tolerance test after intake of yogurt
Scientific Title
Sucrose tolerance test for human after intake of yogurt with blood glucose elevation inhibitory effect
Scientific Title:Acronym
Sucrose tolerance test after intake of yogurt
Region
| Japan |
Condition
Condition
Diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of yogurt on postprandial hyperglycemia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postprandial blood glucose levels
Area under the curve (AUC) of postprandial plasma glucose levels
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Sucrose tolerance test is conducted under the conditions of both yogurt intake(single ingestion 200ml) and no yogurt intake at an interval of 2days or more.
Interventions/Control_2
Sucrose tolerance test is conducted under the conditions of both yogurt intake(single ingestion 200ml) and no yogurt intake at an interval of 2days or more.
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Subject who are the age of 20 to less than the age of 60 years old.
2) Healthy adult Male and Female
3) Subjects who can make self-judgment and are voluntarily giving written informed consent
Key exclusion criteria
1) Diabetes patients on treatment
2) Subjects who have dairy products allergy.
3) Subjects who use oral medication and constantly consume supplements affecting blood glucose.
4) Subjects who constantly use pharmaceuticals for chronic malady.
5) Subjects who have a history of digestive disease affecting digestion and absorption.
6) Subjects who are judged as unsuitable for the study by the investigator for other reasons.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Setsuo Hasegawa |
Organization
Pharmaspur Inc.
Division name
Pharmaspur Inc.
Zip code
Address
Toyo Building, 1-2-10 Nihonbashi, Chuo-ku, Tokyo
TEL
03-6214-2670
setsuo_hasegawa@pharmaspur.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michiko Kaiuma |
Organization
Pharmaspur Inc.
Division name
Pharmaspur Inc.
Zip code
Address
Toyo Building, 1-2-10 Nihonbashi, Chuo-ku, Tokyo
TEL
03-6214-2670
Homepage URL
michiko_kainuma@pharmaspur.com
Sponsor or person
Institute
Pharmaspur Inc.
Institute
Department
Personal name
Funding Source
Organization
University of Tokyo
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 01 | Month | 31 | 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 | 27 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 31 | 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
| 2016 | Year | 01 | Month | 30 | Day |
Last modified on
| 2017 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024021
| 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 |
