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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018800
Receipt No. R000021751
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 2015/08/25
Last modified on 2016/03/28

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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.)
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
Key inclusion criteria A teaching stuff and a student of University of Niigata Prefecture
Key exclusion criteria Diabetics
Target sample size 2

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
Email 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
Email tanabena@gmail.com

Sponsor
Institute Faculty of Human Life Studies, University of Niigata Prefecture
Institute
Department

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
Email

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
2015 Year 08 Month 25 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
2015 Year 07 Month 28 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 27 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
2015 Year 08 Month 25 Day
Last modified on
2016 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021751

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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