UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039555 |
|---|---|
| Receipt number | R000045097 |
| Scientific Title | An investigation study of the glycemic index (GI): an open-label trial |
| Date of disclosure of the study information | 2020/02/21 |
| Last modified on | 2020/11/24 10:17:31 |
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Basic information
Public title
An investigation study of the glycemic index (GI)
Acronym
An investigation study of the glycemic index (GI)
Scientific Title
An investigation study of the glycemic index (GI): an open-label trial
Scientific Title:Acronym
An investigation study of the glycemic index (GI)
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
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
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 1: sugar
Test food 2: sugar containing sugarcane polyphenol
Reference food: Trelan-G 50 g
Administration:
<Test food 1> After taking blood samples before intake, dissolve test food 1 in water (150 mL) and drink within 15 minutes.
<Test food 2> After taking blood samples before intake, dissolve test food 2 in water (150 mL) and drink within 15 minutes.
<Reference food> After taking blood samples before intake, drink reference food within 15 minutes.
* The intervention sequence is reference food, reference food, test food 1 to test food 2 and each beverage is single ingestion.
* Washout period between each ingestion is for one week and more.
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 not more than 30 kg/m2 in BMI
3. Subjects who are judged as eligible to participate in the study by the physician
Key exclusion criteria
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who have food allergies and/or food intolerances. Particularly, subjects who have lactose intolerance.
5. Subjects who have abnormal glucose tolerance
6. Subjects who take medications known to affect glucose tolerance
7. Subjects who have used insulin to treat diabetes or taken antihyperglycemic drugs
8. Subjects who are the presence or under the treatment of disease which influence digestion and absorption of nutrients
9. Subjects who are taking steroids, protease inhibitors, or antipsychotics
10. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily
11. Subjects who are currently taking medicines (include herbal medicines) and supplements
12. Subjects who are allergic to medicines and/or the test food related products
13. Subjects who are pregnant, breast-feeding, and planning to become pregnant
14. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial
15. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | YAMAMOTO |
Organization
ORTHOMEDICO Inc.
Division name
CEO
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
kazu@orthomedico.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | SUZUKI |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
ENSUIKO SUGAR REFINING CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel
03-5793-3623
info@takara-clinic.com
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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 21 | 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
10
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
| 2020 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 21 | Day |
Last modified on
| 2020 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045097
