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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036338
Receipt No. 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 2019/07/11

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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
Email 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
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

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
Email 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 No longer recruiting
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 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041401

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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