UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038956 |
|---|---|
| Receipt number | R000044134 |
| Scientific Title | A Study on the Effect of Plant Extract on Postprandial Blood Glucose and Serum Triglyceride -A Randomized, Double-blind, Placebo-controlled, Cross-over Study- |
| Date of disclosure of the study information | 2020/01/05 |
| Last modified on | 2023/12/07 10:28:43 |
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Basic information
Public title
A Study on the Effect of Plant Extract on Postprandial Blood Glucose and Serum Triglyceride
-A Randomized, Double-blind, Placebo-controlled, Cross-over Study-
Acronym
A Study on the Effect of Plant Extract on Postprandial Blood Glucose and Serum Triglyceride
Scientific Title
A Study on the Effect of Plant Extract on Postprandial Blood Glucose and Serum Triglyceride
-A Randomized, Double-blind, Placebo-controlled, Cross-over Study-
Scientific Title:Acronym
A Study on the Effect of Plant Extract on Postprandial Blood Glucose and Serum Triglyceride
Region
| Japan |
Condition
Condition
No (include borderline diabetes)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect of plant extract on postprandial blood glucose and serum triglyceride
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose AUC and Serum triglyceride AUC
Key secondary outcomes
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
Powder containing plant extract, 1 sachet per serving
Interventions/Control_2
Powder not containing plant extract, 1 sachet per serving
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy males and females aged 20 to 64 year-old.
(2) Subjects who have enough information about its objective and details, can make self-judgment and voluntarily give written informed consent before they agree to participate.
(3) Subjects who can obey the directions of the investigators.
Key exclusion criteria
(1) Subjects whose fasting blood glucose level is 126 mg/dL and over or two-hour blood glucose level after 75 g glucose loading is 200 mg/dL and over and/or who have been diagnosed with diabetes.
(2) Subjects whose fasting serum triglyceride level is 45 mg/dL or less and 150 mg/dL or over, or casual serum triglyceride level is 650 mg/dL and over.
(3) Subjects who contract or are under treatment for serious diseases (e.g., diabetes, liver disease, kidney disease, digestive system disease, heart disease, respiratory disease, peripheral vascular disorder, etc.).
(4) Subjects who use oral medication affecting blood glucose or lipid metabolism.
(5) Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses, Foods with Functional Claims) affecting blood glucose or lipid metabolism.
(6) Subjects with abnormal parameters in liver and/or kidney function.
(7) Subjects who have a history of digestive disease surgery.
(8) Subjects with a disease that may have an influence on this study currently under treatment.
(9) Subjects who have declared an allergic reaction to test foods, or loading foods.
(10) Subjects with anemia or who have difficulty with self blood collection.
(11) Subjects who play high intensity sports and/or are on a diet.
(12) Subjects with irregular life patterns.
(13) Subjects who use medicines (including OTC and/or prescribed medications) continuously.
(14) Subjects who drink excessive alcohol, or who can't stop drinking from one day before each measurement.
(15) Subjects who are planning to become pregnant after informed consent for the current study or are pregnant or lactating.
(16) Subjects who are planning to participate in other clinical studies.
(17) Subjects who are judged as unsuitable for the study by the investigator for other reasons.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shinichiro |
| Middle name | |
| Last name | Takashima |
Organization
TOYO SHINYAKU Co., Ltd.
Division name
Clinical and analytical research center
Zip code
841-0005
Address
7-28 Yayoigaoka, Tosu-Shi, Saga, Japan
TEL
0942-81-3555
takashimas@toyoshinyaku.co.jp
Public contact
Name of contact person
| 1st name | Nobutaka |
| Middle name | |
| Last name | Kusaba |
Organization
TOYO SHINYAKU Co., Ltd.
Division name
Clinical and analytical research center
Zip code
841-0005
Address
7-28 Yayoigaoka, Tosu-Shi, Saga, Japan
TEL
0942-81-3555
Homepage URL
gakujutsu@toyoshinyaku.co.jp
Sponsor or person
Institute
TOYO SHINYAKU Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
TOYO SHINYAKU 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
Miura Clinic, Medical Corporation Kanonkai IRB
Address
9F Higashitenma building, 1-7-17 Higashitenma, Kita-ku, Osaka, Osaka, Japan
Tel
06-6135-5200
mterashima@miura-cl.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 | 01 | Month | 05 | Day |
Related information
URL releasing protocol
http://www.pieronline.jp/content/article/0386-3603/48060/1065
Publication of results
Published
Result
URL related to results and publications
http://www.pieronline.jp/content/article/0386-3603/48060/1065
Number of participants that the trial has enrolled
20
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 06 | Month | 30 | Day |
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 | 10 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 10 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 12 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 13 | Day |
Date analysis concluded
| 2020 | Year | 04 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 23 | Day |
Last modified on
| 2023 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044134
