UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046402 |
|---|---|
| Receipt number | R000052913 |
| Scientific Title | Measuring the glycemic index (GI) of fruit extract |
| Date of disclosure of the study information | 2021/12/17 |
| Last modified on | 2022/06/17 09:41:09 |
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Basic information
Public title
Measuring the glycemic index (GI) of fruit extract
Acronym
Measuring the glycemic index (GI) of fruit extract
Scientific Title
Measuring the glycemic index (GI) of fruit extract
Scientific Title:Acronym
Measuring the glycemic index (GI) of fruit extract
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure the glycemic index (GI) of the test food
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
GI
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
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Duration: single dose
Test food: Fruit Extract 71.4 g
Reference food1: Glucose 25 g
Reference food2: Glucose 15.5 g + Fructose 9.5 g
Administration:
<Test food> After taking blood samples before intake, dissolve the test food in 150 mL of water and drink it.
<Reference food> After taking blood samples before intake, dissolve the reference food in 150 mL of water and drink it.
* The intervention sequence order is 1) reference food1, 2) reference food1, 3) test food and 4) reference food2.
* Washout period between each intervention is for one day and more.
* This study conforms to the standards of ISO 26642: 2010.
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Healthy Japanese adult subjects
2.Subjects who are 30 kg/m^2 or less in BMI
3.Subjects who have written consent for participation in the study
Key exclusion criteria
1.Subjects with a history of diabetes, cirrhosis, chronic hepatitis, renal failure, heart failure, cerebral infarction, cerebral hemorrhage, myocardial infraction, angina pectoris, a history of cancer, or a history of surgery of the digestive system (esophagus, stomach, duodenum, small intestine, large intestine, rectal, gallbladder, pancreas)
2.Subjects who currently have a disease under treatment
3.Subjects with fruit allergies
4.Subjects who have abnormal glucose tolerance
5.Subjects who take medications known to affect glucose tolerance
6.Subjects who a pregnant, breast-feeding, and planning to become pregnant or breast-feeding
7.Subjects who are participating in other clinical trials or scheduled to participate in the trial or are less than three months after the end of the trial
8.Subjects judged inappropriate by the doctor responsible for the examination
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Miura |
Organization
Medical Corporation Kanonkai, Miura clinic
Division name
Internal medicine
Zip code
530-0044
Address
Higashitenma Bldg. 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL
06-6135-5200
info@miura.co.jp
Public contact
Name of contact person
| 1st name | Yukino |
| Middle name | |
| Last name | Koshinaka |
Organization
Miki Corporation
Division name
Institute for Health science
Zip code
663-8142
Address
12-4, Naruohama 3, Nishinomiya, Hyogo
TEL
0798-43-1870
Homepage URL
koshinaka@mikiprune.co.jp
Sponsor or person
Institute
Oneness Support Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Miki Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Miura Clinic, Medical Corporation Kanonkai
Address
Higashitenma Bldg. 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
Tel
06-6135-5200
koshinaka@mikiprune.co.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 17 | 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
| 2021 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2022 | 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
| 2021 | Year | 12 | Month | 17 | Day |
Last modified on
| 2022 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052913
