UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041578 |
|---|---|
| Receipt number | R000047469 |
| Scientific Title | Effect of ONR-13 on Postprandial Glucose Response in Healthy Volunteers -A Randomized, Double-blind, Placebo-controlled, Crossover Study- |
| Date of disclosure of the study information | 2020/08/31 |
| Last modified on | 2021/02/26 12:30:47 |
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Basic information
Public title
Effect of ONR-13 on Postprandial Glucose Response in Healthy Volunteers
-A Randomized, Double-blind, Placebo-controlled, Crossover Study-
Acronym
ONR-13 for attenuation of blood glucose levels after meal in Healthy Volunteers
Scientific Title
Effect of ONR-13 on Postprandial Glucose Response in Healthy Volunteers
-A Randomized, Double-blind, Placebo-controlled, Crossover Study-
Scientific Title:Acronym
ONR-13 for attenuation of blood glucose levels after meal in Healthy Volunteers
Region
| Japan |
Condition
Condition
Healthy Volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To check acute blood glucose levels of healthy volunteers after meal with and without ONR-13 and see if ONR-13 has a health benefit.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postprandial circulating peptide hormone level
Key secondary outcomes
Postprandial blood glucose level
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single oral administration of ONR-13
Interventions/Control_2
Single oral administration of Placebo
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) Subjects who are voluntarily giving written informed consent.
2) Healthy volunteers aged between 20 and 49.
3) Healthy volunteers BMI between 18.5 and 29.9.
4) Fasting blood glucose less than 126mg/dL.
5) 120-minute blood glucose value less than 200 mg/dl during an OGTT (oral glucose tolerance test) with a 75 g glucose load.
Key exclusion criteria
(1) Subjects who cause allergic symptoms in foods and medicines.
(2) Subjects who contract or are under treatment for diseases (e.g., liver disease, kidney disease, heart disease, respiratory disease, digestive disease and/or metabolic disease).
(3) Subjects who have donated over 400 mL of blood within the last three months, over 200 mL of blood within the last one month or over blood components within the last two weeks prior to the current study.
(4) Subjects with systolic blood pressure of 160 mmHg or more or diastolic blood pressure of 100 mmHg or more at screening test.
(5) Subjects whose systolic blood pressure is less than 90 mmHg.
(6) Subjects who are pregnant or planning to become pregnant after informed consent and who wish to become pregnant during this study or who cannot consent appropriate contraception.
(7) Subjects who are lactating.
(8) Subjects who are not negative for syphilis, HBs antigen, HCV antibody or HIV antigen/antibody test.
(9) Alcoholic drinkers (more than 40 grams of pure alcohol per day) and subjects who smoke more than 20 cigarettes a day.
(10) Subjects who are shiftworker and/or midnight-shift worker.
(11) Subjects who can't stop using, medicin, supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) during test periods.
(12) Subjects who are under treatment for or have a history of drug addiction.
(13) Subjects who are planning to participate in other clinical studies during test periods and/or had participated in other clinical studies within the last one month prior to the current study.
(14) Subject who can't keep the daily records.
(15) Subjects who are judged unsuitable for the current study by the investigator for other reasons.
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Kouda |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Otsu Nutraceuticals Research Institute
Zip code
520-0002
Address
3-31-13 Saigawa, Otsu-city, Shiga
TEL
077-521-8835
Kohda.Noriyuki@otsuka.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Noguchi |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Otsu Nutraceuticals Research Institute
Zip code
520-0002
Address
3-31-13 Saigawa, Otsu-city, Shiga
TEL
077-521-8835
Homepage URL
Noguchi.Hiroki@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuhara Clinic Clinical Trial Review Committee
Address
1-15, Shimamatsuhigashimachi-3-chome, Eniwa-shi, Hokkaido
Tel
0123-36-8029
d-kameda@mediffom.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
| 2020 | Year | 08 | Month | 31 | 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
| 2020 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | 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
| 2020 | Year | 08 | Month | 27 | Day |
Last modified on
| 2021 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047469
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