UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036338 |
|---|---|
| Receipt number | R000041401 |
| Scientific Title | Suppressive effect of test food on the postprandial blood glucose level |
| Date of disclosure of the study information | 2019/03/29 |
| Last modified on | 2019/11/20 09:37:41 |
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Basic information
Public title
Suppressive effect of test food on the postprandial blood glucose level
Acronym
Suppressive effect of test food on the postprandial blood glucose level
Scientific Title
Suppressive effect of test food on the postprandial blood glucose level
Scientific Title:Acronym
Suppressive effect of test food on the postprandial blood glucose level
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of test food on the postprandial blood glucose level of subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Postprandial blood glucose level (Cmax)
Key secondary outcomes
Postprandial insulin level (AUC,Cmax)
Postprandial blood glucose levels and insulin levels of 30, 60, 90, and 120 minutes after control food ingestion
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of test food, and then intake of placebo after wash out period
Interventions/Control_2
Intake of placebo, and then intake of test food after wash out period
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
a) Persons who consent to participate in the study, and signed the consent form
b) Persons whose fasting blood glucose levels are between 90 and 125 mg/dL
c) Persons whose postprandial blood glucose levels increased enough
d) Persons who are judged suitable to participate in this trial by physician
Key exclusion criteria
a) Persons who have previous medical history of malignant tumor or heart failure or myocardial infarction
b) Person who hasn't used a cardiac pacemaker or implantable cardioverter defibrillators
c) Patients being treated for at least one of following diseases atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension and other chronic disease
d) Persons who routinely take foods for specified health uses, foods with function claims and other functional foods/drinks
e) Persons who continually take medicines (including herbal medicine) and supplements
f) Persons who are allergic to medicines, or products related to the test material of this trial
g) Pregnant women, lactating women, or women who want to get pregnant during the trial period
h) Persons who are judged not suitable to participate in this trial by physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | YAMAMOTO |
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, 112-0002 Japan
TEL
+81-3-3818-0610
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, 112-0002 Japan
TEL
+81-3-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
Zenyaku Kogyo Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Seishin-kai Medical Association Inc, Takara Medical Clinic.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Seishin-kai medical association Inc, Takara medical clinic
Address
9F Taisei Building, 2-3-2 Higashi-gotanda, Shinagawa-ku, Tokyo, 141-0022 Japan
Tel
+81-3-5793-3623
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）/Seishin-kai Medical Association Inc,Takara Clinic (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | 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
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 | 03 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 22 | 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 | 03 | Month | 29 | Day |
Last modified on
| 2019 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041401
