UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045463 |
|---|---|
| Receipt number | R000051907 |
| Scientific Title | Study on suppression of blood glucose elevation by consumption of research foods (preliminary test) 3 groups. |
| Date of disclosure of the study information | 2021/09/17 |
| Last modified on | 2022/03/14 18:32:55 |
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Basic information
Public title
Study on suppression of blood glucose elevation by consumption of research foods (preliminary test) 3 groups.
Acronym
Study on suppression of blood glucose elevation by consumption of research foods (preliminary test) 3 groups.
Scientific Title
Study on suppression of blood glucose elevation by consumption of research foods (preliminary test) 3 groups.
Scientific Title:Acronym
Study on suppression of blood glucose elevation by consumption of research foods (preliminary test) 3 groups.
Region
| Japan |
Condition
Condition
Healthy adult male
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the inhibitory effect on the increase in blood glucose level of 75 g OGTT and safety when the food containing pentadecyl-containing auran oil is ingested continuously for 4 weeks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area under the curve of blood glucose level (AUC), Area under the rising curve of blood glucose level (IAUC)
Evaluate at points of 4 week of intake period.
Key secondary outcomes
Area under the curve of insulin level (AUC), Area under the rising curve of insulin level (IAUC), insulinogenic index, Fasting blood glucose level, HbA1c
Evaluate at points of 4 week of intake period.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
1 grains of the test product daily oral intake for 4 weeks.
Interventions/Control_2
2 grains of the test product daily oral intake for 4 weeks.
Interventions/Control_3
4 grains of the test product daily oral intake for 4 weeks.
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
| 64 | years-old | >= |
Gender
Male
Key inclusion criteria
Male between 20 and 64 years of age.
Key exclusion criteria
(1) Subjects who regularly use functional foods or supplements containing omega-3 fatty acids such as DHA, EPA, and Alpha-linolenic acid.
(2) Subjects who regularly use functional foods or supplements containing algae (e.g., aurantiochytrium, euglena, spirulina, greenbug, etc.)
(3) Subjects who regularly use medicines, health foods, foods for specified health uses, or functional foods that may affect blood glucose metabolism.
(4) Subjects who are under treatment or have a history of serious diseases (e.g., diabetes, liver disease, kidney disease, or heart disease).
(5) Subjects who have a disease under treatment, or a serious or pre-existing disease that requires medication.
(6) Subjects with diseases that may cause diabetes or abnormalities in glucose metabolism, and subjects with a history of such diseases (e.g., pancreatic diseases, endocrine disorders, gastrectomy)
(7) Subjects having possibilities for emerging allergy related to the study.
(8) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination before intake.
(9) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study.
(10) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire and other questionnaires.
(11) Subjects who have donated of blood within 1 month before beginning pre-inspection.
(12) Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | Yasuko |
| Middle name | |
| Last name | Sakata |
Organization
Sea Act Co., LTD
Division name
Planning & Development
Zip code
100-0005
Address
2-2-1 Marunouchi, Chiyoda-ku, Tokyo
TEL
03-6268-0040
sakata-yasuko@refine-hd.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Ikeda |
Organization
EP Mediate Co., Ltd.
Division name
Development Business Headquarters, TTC Center, Trial Planning Department
Zip code
162-0822
Address
Tsuruya Bldg., 2-23 Shimomiyabicho, Shinjuku-ku, Tokyo
TEL
090-4964-4061
Homepage URL
ikeda.masahiro083@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Sea Act Co., LTD
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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguroku, Tokyo
Tel
03-6452-2712
saito.teruo876@eps.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 | 09 | 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
9
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 | 09 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 15 | 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 | 09 | Month | 13 | Day |
Last modified on
| 2022 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051907
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
