UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022655 |
|---|---|
| Receipt number | R000026118 |
| Scientific Title | A pilot study on the effects of dietary conditions on blood glucose response and insulin secretion after white rice intake |
| Date of disclosure of the study information | 2016/06/08 |
| Last modified on | 2016/12/21 14:57:01 |
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Basic information
Public title
A pilot study on the effects of dietary conditions on blood glucose response and insulin secretion after white rice intake
Acronym
Dietary conditions and post-prandial glucose metabolism
Scientific Title
A pilot study on the effects of dietary conditions on blood glucose response and insulin secretion after white rice intake
Scientific Title:Acronym
Dietary conditions and post-prandial glucose metabolism
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of chewing frequency of rice and eating order of vegetables and rice on post-prandial responses of blood glucose levels and insulin secretion.
Basic objectives2
Others
Basic objectives -Others
Physiological response
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Capillary blood glucose levels, fasting and post-prandial (15, 30, 45, 60, 90,120 min.)
Subcutaneous glucose levels measured by use of a continuous glucose monitoring device
Plasma glucose levels, fasting and post-prandial (30 min.)
Serum insulin levels, fasting and post-prandial (30 min.)
Urinary C-peptide in a 3-hour urine sample after starting each meal
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
Uncontrolled
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
･Eating 147g of cooked white
rice (chewing each mouthful
>=30 times) for 1 breakfast
･Eating 147g of cooked white
rice (chewing each mouthful <5
times) for 1 breakfast
･Eating 147g of cooked white
rice (chewing each mouthful
>=30 times) after eating 130g of
steamed eggplants for 1
breakfast
･Eating 147g of cooked white
rice (chewing each mouthful<5
times) after eating 130g of
steamed eggplants for 1
breakfast
･Eating 147g of cooked white
rice (chewing each mouthful
>=30 times) with 130g of
steamed eggplants for 1
breakfast
･Eating 147g of cooked white
rice (chewing each mouthful<5
times) with 130g of steamed
eggplants for 1 breakfast
･Single test of oral 50g glucose
load
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A teaching stuff and students of University of Niigata Prefecture
Key exclusion criteria
Diabetics
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
025-368-8240
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
025-368-8240
Homepage URL
tanabena@gmail.com
Sponsor or person
Institute
Faculty of Human Life Studies, University of Niigata Prefecture
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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 | 06 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 06 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | 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 | 06 | Month | 08 | Day |
Last modified on
| 2016 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026118
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
