UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021331 |
|---|---|
| Receipt number | R000024599 |
| Scientific Title | Numbers of type 2 diabetes susceptibility genes define altered-yogurt effects on glucose and insulin responses: a pilot study with healthy volunteers. |
| Date of disclosure of the study information | 2016/03/04 |
| Last modified on | 2016/03/11 11:12:58 |
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Basic information
Public title
Numbers of type 2 diabetes
susceptibility genes define
altered-yogurt effects on glucose and insulin responses: a pilot study with healthy volunteers.
Acronym
Yogurt intervention study
Scientific Title
Numbers of type 2 diabetes
susceptibility genes define
altered-yogurt effects on glucose and insulin responses: a pilot study with healthy volunteers.
Scientific Title:Acronym
Yogurt intervention study
Region
| Japan |
Condition
Condition
healthy young
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Observational studies have investigated interaction of genetic and environmental risk factors in Western populations. However, data from Japanese population are limited. We aimed to investigate whether numbers of validated type 2 diabetes susceptibility genes that are associated with modulation on incidence of type 2 diabetes is associated with glucose and insulin responses during rice ingestion in healthy volunteers. Moreover, altered-yogurt effects on glucose and insulin responses investigated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Primary outcome is defined as blood glucose area under the curve (AUC), insulin AUC, HOMA-IR, HOMA-beta, 1/Fasting insulin, Insulinogenic Index (IGI), incAUC ins/glu and Oral Disposition Index (DI). All outcomes evaluated before and after the yogurt consumption for 4-weeks.
Key secondary outcomes
HbA1c, total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride, body fat.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
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 150g/day non-fat yogurt for 4 weeks
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
| 29 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Can do intake of 150g/day non-fat yogurt for 4 weeks
Key exclusion criteria
1) Participant with food allergy
2) Participant intake dairy on a daily basis
3) Recipients of medicine
4) Smokers
5) Abnormal glucose tolerance was seen in the past one year
6) BMI>30kg/m2
Target sample size
29
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sachi Kuranuki |
Organization
Kanagawa University of Human Services
Division name
Department of Nutrition & Dietetics
Zip code
Address
1-10-1,Heisei-cho,Yokosuka,Kanagawa,Japan
TEL
046-828-2664
kuranuki-s@kuhs.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daiki Watanabe |
Organization
Kanagawa University of Human Services
Division name
Department of Nutrition & Dietetics
Zip code
Address
1-10-1,Heisei-cho,Yokosuka,Kanagawa, Japan
TEL
046-828-2664
Homepage URL
watanabe.smusm.1021@gmail.com
Sponsor or person
Institute
Kanagawa University of Human Services
Institute
Department
Personal name
Funding Source
Organization
DANONE JAPAN
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
St. Marianna University School of Medicine.
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
神奈川県立保健福祉大学/Kanagawa University of Human Services
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 04 | 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
| 2014 | Year | 01 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 12 | Day |
Date of closure to data entry
| 2014 | Year | 11 | Month | 20 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 06 | Day |
Date analysis concluded
| 2015 | Year | 01 | Month | 05 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 04 | Day |
Last modified on
| 2016 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024599
