![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000036979 |
Receipt No. | R000042129 |
Scientific Title | A confirmation study of the inhibitory effect of blood glucose increasing by consumption of the test drink |
Date of disclosure of the study information | 2020/06/09 |
Last modified on | 2020/10/09 |
Basic information | ||
Public title | A confirmation study of the inhibitory effect of blood glucose increasing by consumption of the test drink | |
Acronym | A confirmation study of the inhibitory effect of blood glucose increasing by consumption of the test drink | |
Scientific Title | A confirmation study of the inhibitory effect of blood glucose increasing by consumption of the test drink | |
Scientific Title:Acronym | A confirmation study of the inhibitory effect of blood glucose increasing by consumption of the test drink | |
Region |
|
Condition | ||
Condition | Healthy adult | |
Classification by specialty |
|
|
Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To confirm the elevation inhibitory effect of blood glucose and of blood triglyceride by consumption of the test drink. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | *Area under the concentration time curve of blood glucose
*Area under the concentration time curve of blood insulin |
Key secondary outcomes | *Area under the concentration time curve of blood triglyceride
*Blood glucose level of each measuring point *Blood insulin level of each measuring point *Blood triglyceride level of each measuring point *Cmax of blood glucose level *Tmax of blood glucose level *Cmax of blood insulin level *Tmax of blood insulin level *Cmax of blood triglyceride level *Tmax of blood triglyceride level *The incidence of side effects and/or adverse events |
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 |
|
|
Interventions/Control_1 | Consume one bottle (50 mL) of test drink 5 min before the load food intake. Rest more than 5 days. Consume one bottle (50 mL) of control drink 5 min before the load food intake. | |
Interventions/Control_2 | Consume one bottle (50 mL) of control drink 5 min before the load food intake. Rest more than 5 days. Consume one bottle (50 mL) of test drink 5 min before the load food intake. | |
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 |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | 1) Male and Females aged 20 to 64 when informed consent.
2) Subjects their fasting blood glucose are between 110 and 125 mg/dL or their blood glucose level of 120 min after OGTT are between 140 and 199 mg/dL. 3) Subjects who receive enough explain of the test, who deeply understanding of the test, and who obtain own consent to participate the test. |
|||
Key exclusion criteria | 1) Subjects who are being received treatment and/or medication when informed consent.
2) Subjects who are not able to quit intake medicine, food for specific health, functional food and/or supplement having a possibility of affecting blood glucose level during test period. 3) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period. 4) Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ). 5) Subjects who excessive alcohol intake. 6) Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work. 7) Subjects who excessive alcohol intake. 8) Subjects who have weak digestive organ and/or have tendency of diarrhea. 9) Subjects who show more than 6.5 % in HbA1c level at preliminary test. 10) Subjects who show more than 160 mg/dL in fasting blood glucose level measured by glucose sensor at preliminary test. 11) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests. 12) Subjects who donated over 200 mL blood and/or blood components within the last one month to the current study. 13) Subjects who donated over 400mL blood and/or blood components within the last three months to the current study. 14) Females who donated over 400mL blood and/or blood components within the last four months to the current study. 15) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve months are adding to the planned sampling amounts of this study. 16) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve months are adding to the planned sampling amounts of this study. 17) Others they have been determined ineligible by principal investigator or sub-investigator. |
|||
Target sample size | 10 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | CPCC Company Limited | ||||||
Division name | Division of Clinical Research | ||||||
Zip code | 101-0047 | ||||||
Address | 4F Sanwauchikannda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN | ||||||
TEL | 03-5297-3112 | ||||||
cpcc-contact@cpcc.co.jp |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | CPCC Company Limited | ||||||
Division name | Planning & Sales Department | ||||||
Zip code | 101-0047 | ||||||
Address | 4F Sanwauchikannda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN | ||||||
TEL | 03-5297-3112 | ||||||
Homepage URL | |||||||
cpcc-contact@cpcc.co.jp |
Sponsor | |
Institute | CPCC Company Limited |
Institute | |
Department |
Funding Source | |
Organization | Mannanlife 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 | Institutional Review Board of Chiyoda Paramedical Care Clinic |
Address | 2F Sanwauchikannda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan |
Tel | 03-5297-5548 |
IRB@cpcc.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 |
|
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 |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042129 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |