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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034009
Receipt No. R000038748
Scientific Title Study on the influence on sugar metabolism by food intake.
Date of disclosure of the study information 2018/09/05
Last modified on 2018/12/14

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Basic information
Public title Study on the influence on sugar metabolism by food intake.
Acronym Study on the influence on sugar metabolism by food intake.
Scientific Title Study on the influence on sugar metabolism by food intake.
Scientific Title:Acronym Study on the influence on sugar metabolism by food intake.
Region
Japan

Condition
Condition Healthy volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Previous studies have reported that proteins, lipids, vinegar (acetic acid) and dietary fiber contained in foods have an effect of alleviating an increase in postprandial blood glucose level when cooked with carbohydrates.
The purpose of this study is to examine how the amount of each nutrient component affects the change in blood glucose level after meals by changing the amount of food serving as an indicator of these nutritional ingredients and ingesting them. By using the results of the verification, we obtain information to estimate the influence on the postprandial blood glucose level when combined foods containing various nutrients are cooked with carbohydrates.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes a blood-glucose level of before and 15,30,45,60,90,and 120 minutes after test food
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 10
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Take 200 g of white rice in 5 minutes.
Interventions/Control_2 Take 200 g of white rice and 50 g of steamed chicken in 10 minutes.
Interventions/Control_3 Take 200 g of white rice and 110 g of stemade chicken in 10 minutes.
Interventions/Control_4 Take 200 g of white rice and 14 g of olive oil in 10 minutes.
Interventions/Control_5 Take 200 g of white rice and 28 g of olive oil in 10 minutes.
Interventions/Control_6 Take 200 g of white rice and 15 g of grain vinegar in 10 minutes.
Interventions/Control_7 Take 200 g of white rice and 30 g of grain vinegar in 10 minutes.
Interventions/Control_8 Take 200 g of white rice and 5.2 g of indigestible dextrin in 10 minutes.
Interventions/Control_9 Take 200 g of white rice and 10.4 g of indigestible dextrin in 10 minutes.
Interventions/Control_10 Take 200 g of white rice and 50 g of cabbage in 10 minutes.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
30 years-old >
Gender Male and Female
Key inclusion criteria [1]Aged between 20 and 29
[2]Individuals who are healthy and do not treat any disease
[3]Individuals whose written informed consent has been obtained
[4]Individuals who can have an examination on a designated check day
[5]Individuals judged appropriate for the study by the principal
Key exclusion criteria [1]Individuals using medical products
[2]Individuals who are or are under treatment or have a history of Impaired Glucose Tolerance, mental disabilities, sleep disorder, hypertension, diabetes, fat metabolism or the other serious dysfunctions
[3]Individuals who used a drug to treat in the past 1 month (One-shot medicine of a headache, menstrual pain and a cold removes it.)
[4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung disease, or blood disease
[5]Individual who have digestive organ disease(disease of an appendix is removed)
[6]Individuals whose BMI is over 30 kg/m2
[7]Individuals who donated blood over 200mL in the past 1 month or over 400 mL in the past 3 months
[8]Individuals with serious anemia
[9]Individuals who are sensitive to test products or Individual with fear who causes severe allergy in a food and medical supplies
[10]Individuals who is pregnant or lactate
[11]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements of glycometabolism in the past 3 month or will ingest those foods during the test period
[12]Individuals judged inappropriate for the study by the principal
Target sample size 17

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayuki Yagi
Organization Faculty of Life and Medical Sciences, Doshisha University
Division name Glycative Stress Research Center
Zip code
Address 1-3 Tatara Miyakodani,Kyotanabe City, Kyoto
TEL 0774-65-6394
Email myagi@mail.doshisha.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masayuki Yagi
Organization Faculty of Life and Medical Sciences, Doshisha University
Division name Glycative Stress Research Center
Zip code
Address 1-3 Tatara Miyakodani,Kyotanabe City, Kyoto
TEL 0774-65-6394
Homepage URL
Email myagi@mail.doshisha.ac.jp

Sponsor
Institute Doshisha University
Institute
Department

Funding Source
Organization Glycative Stress Research Center,Faculty of Life and Medical Sciences, Doshisha University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) Japanese Council for Science, Technology and Innovation (CSTI), Cross-ministerial Strategic Innovation Promotion Program

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
2018 Year 09 Month 05 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 No longer recruiting
Date of protocol fixation
2018 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information [Interventions/Control_11]Take 200 g of white rice and 100 g of cabbage in 10 minutes
[Interventions/Control_12]Take 200 g of white rice, 150 g of dumpling, 15 g of ponzu sauce in 10 minutes.

Management information
Registered date
2018 Year 09 Month 03 Day
Last modified on
2018 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038748

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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