UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035699 |
|---|---|
| Receipt number | R000040665 |
| Scientific Title | Study of the inhibitory effect of spice on intermediate of AGEs after steamed rice intake. |
| Date of disclosure of the study information | 2019/01/29 |
| Last modified on | 2019/07/30 09:02:34 |
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Basic information
Public title
Study of the inhibitory effect of spice on intermediate of AGEs after steamed rice intake.
Acronym
Study of the inhibitory effect of spice on intermediate of AGEs after steamed rice intake.
Scientific Title
Study of the inhibitory effect of spice on intermediate of AGEs after steamed rice intake.
Scientific Title:Acronym
Study of the inhibitory effect of spice on intermediate of AGEs after steamed rice intake.
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In recent years, elevated blood glucose levels after meals, as well as elevated blood levels of intermediates of AGEs that damage vascular endothelial cells have been reported. Based on our research, it has been found that spices contained in curry have an effect of suppressing intermediates of AGEs, so in order to verify the inhibitory effect of spice on intermediates of AGEs after curry and steamed rice intake.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in blood glucose, 3DG, GO, MGO after intake of meals
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Visit-1 steamed rice, visit-2 steamed rice + curry A, visit-3 steamed rice + curry B, visit-4 steamed rice + shredded cabbage
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
| 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
15
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Yagi |
Organization
Faculty of Life and Medical Sciences, Doshisha University
Division name
Glycative Stress Research Center
Zip code
6100394
Address
1-3 Tatara Miyakodani,Kyotanabe City, Kyoto
TEL
0774-65-6394
myagi@mail.doshisha.ac.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Yagi |
Organization
Faculty of Life and Medical Sciences, Doshisha University
Division name
Glycative Stress Research Center
Zip code
6100394
Address
1-3 Tatara Miyakodani,Kyotanabe City, Kyoto
TEL
0774-65-6394
Homepage URL
myagi@mail.doshisha.ac.jp
Sponsor or person
Institute
Doshisha University
Institute
Department
Personal name
Funding Source
Organization
Doshisha University
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
Doshisha University
Address
Karasuma-higashi-iru, Imadegawa-dori, Kamigyo-ku, Kyoto
Tel
075-251-3048
ji-rinri@mail.doshisha.ac.jp
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
同志社大学糖化ストレス研究センター（京都府）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 29 | 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
11
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
| 2019 | Year | 01 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 28 | Day |
Last modified on
| 2019 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040665
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