UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029250 |
|---|---|
| Receipt number | R000033360 |
| Scientific Title | Study on efficacy and characteristics of the population indicating suppression of the postprandial glucose spike with the general or health food |
| Date of disclosure of the study information | 2017/10/16 |
| Last modified on | 2023/01/01 11:56:56 |
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Basic information
Public title
Study on efficacy and characteristics of the population indicating suppression of the postprandial glucose spike with the general or health food
Acronym
Hyperglycemia suppression trial with foods
Scientific Title
Study on efficacy and characteristics of the population indicating suppression of the postprandial glucose spike with the general or health food
Scientific Title:Acronym
Hyperglycemia suppression trial with foods
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the effects of various general or health foods on postprandial glucose levels (short term) and glycation product (long term)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose (iGP, MAGE, iAUC)(short term)
Change in HbA1c (long term)
Key secondary outcomes
iAUC of postprandial blood glucose level upto 2 hours after intake.
Blood pressure, serum lipids, weight etc.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
7
Purpose of intervention
Prevention
Type of intervention
| Food | Device,equipment |
Interventions/Control_1
Soybean milk 200 mL, b id, 1 week
Interventions/Control_2
Drink containing indigestible dextrin 350 mL, tid, 1 week
Interventions/Control_3
Powder with indigestible dextrin 6 g, tid, 1 week
Interventions/Control_4
Tablet containing salacia-derived salacinol 0.32 g, tid, 1 week
Interventions/Control_5
Guava tea 200 mL, tid, 1 week
Interventions/Control_6
Mulberry leaves tea 2 g, tid, 1 week
Interventions/Control_7
Mulberry leaf extract 2.3 g, tid, 1 week
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Persons aged from 20 to 60y at the consent as a general rule
2) Persons who applied with free will and agreed to participate with a written consent form
3) Either male or female
4) Persons who can have three meals per day almost regularly
Key exclusion criteria
1) Patients diagnosed as diabetes or borderline persons who are undergoing diet, exercise or pharmacotherapy.
2) Fasting blood glucose is more than 126 mg/dL
3) HbA1c is more than 6.5%
4) Persons who are allergic to the test food
5) Persons who are taking some kind of health foods (can participate if the person withdraw its intake)
6) Persons who are pregnant or breastfeeding
7) Persons who are not taking drugs or supplements for hypertension and/or dyslipidemia (long-term exam)
8) Persons who were judged as inappropriate for subjects by the principal investigator
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Noritaka |
| Middle name | |
| Last name | Ariyoshi |
Organization
Okayama University
Division name
Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Zip code
7008558
Address
2-5-1 Shikata-cho, Kita-ku,Okayama, Japan
TEL
086-235-6619
ariyoshi-n@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Noritaka |
| Middle name | |
| Last name | Ariyoshi |
Organization
Okayama University
Division name
Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Zip code
7008558
Address
2-5-1 Shikata-cho, Kita-ku,Okayama, Japan
TEL
086-235-6619
Homepage URL
pmaphs@yahoo.co.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Ethics Committee, Faculty of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
Tel
086-235-6938
mae6605@adm.okayama-u.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
岡山大学/Okayama University
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 22 | Day |
Last modified on
| 2023 | Year | 01 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033360
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
