UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033435 |
|---|---|
| Receipt number | R000038056 |
| Scientific Title | A pilot study on the effects of dietary factors and exercise on postprandial blood glucose response. |
| Date of disclosure of the study information | 2018/07/18 |
| Last modified on | 2018/12/12 10:40:47 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A pilot study on the effects of dietary factors and exercise on postprandial blood glucose response.
Acronym
Effects of dietary factors and exercise on postprandial blood glucose response
Scientific Title
A pilot study on the effects of dietary factors and exercise on postprandial blood glucose response.
Scientific Title:Acronym
Effects of dietary factors and exercise on postprandial blood glucose response
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify how several dietary factors and pre-meal or post-meal exercise influence postprandial blood glucose response
Basic objectives2
Others
Basic objectives -Others
Physiological response
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subcutaneous glucose levels, measured for 3 hours every 5 minutes from the intake of the test meal, using FreeStyle Libre Sensor
Key secondary outcomes
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
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Test meal: cooked rice (150g)
Dietary interventions:
･water (200mL)
･green tea (200mL)
･decaffeinated green tea (200mL)
･rice vinegar (15mL) with water (185 mL)
･unsalted butter (5.4g) with water (200mL)
･olive oil (4.5g) with water (200mL)
Exercise interventions:
･no exercise
･pre-meal low-intensity resistance exercise for 10 min including a 3-min interval
･pre-meal stretching for 10 min including a 3-min interval
･post-meal low-intensity resistance exercise for 10 min including a 3-min interval
･post-meal stretching for 10 min including a 3-min interval
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
| 25 | years-old | > |
Gender
Female
Key inclusion criteria
Students of University of Niigata Prefecture
Key exclusion criteria
･Diebetes
･Taking medicine that can affect glucose metabolism
･Pregnant women
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naohito Tanabe |
Organization
Faculty of Human Life Studies, University of Niigata Prefecture
Division name
Department of Health and Nutrition
Zip code
Address
471 Ebigase, Higashi-ku, Niigata City, Niigata Prefecture, Japan
TEL
+81-25-368-8240
tanabena@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naohito Tanabe |
Organization
Faculty of Human Life Studies, University of Niigata Prefecture
Division name
Department of Health and Nutrition
Zip code
Address
471 Ebigase, Higashi-ku, Niigata City, Niigata Prefecture, Japan
TEL
+81-25-368-8240
Homepage URL
tanabena@gmail.com
Sponsor or person
Institute
University of Niigata Prefecture
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2018 | Year | 07 | Month | 18 | 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
| 2018 | Year | 07 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 23 | 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
| 2018 | Year | 07 | Month | 18 | Day |
Last modified on
| 2018 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038056
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
