UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041013 |
|---|---|
| Receipt number | R000046828 |
| Scientific Title | A Study on the Effect of Food Containing Plant Extract on Postprandial GLP-1 -A Randomized, Double-blind, Placebo-controlled, Cross-over Study- |
| Date of disclosure of the study information | 2020/07/08 |
| Last modified on | 2021/10/26 14:22:53 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Study on the Effect of Food Containing Plant Extract on Postprandial GLP-1
-A Randomized, Double-blind, Placebo-controlled, Cross-over Study-
Acronym
A Study on the Effect of Food Containing Plant Extract on Postprandial GLP-1
Scientific Title
A Study on the Effect of Food Containing Plant Extract on Postprandial GLP-1
-A Randomized, Double-blind, Placebo-controlled, Cross-over Study-
Scientific Title:Acronym
A Study on the Effect of Food Containing Plant Extract on Postprandial GLP-1
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To comfirm the effect of food containing plant extract on Postprandial GLP-1
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
GLP-1
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
Food containing plant extract, single ingestion. Wash out. Food not containing plant extract, single ingestion.
Interventions/Control_2
Food not containing plant extract, single ingestion. Wash out. Food containing plant extract, single ingestion.
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 years-old.
(2)Subjects who do not habitually consume a large amounts of alcohol.
(3)Subjects who are judged not suffering from a disease by the investigator.
(4)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
(1)Subjects who have a chronic disease and regularly use medications.
(2)Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) during test periods.
(3) Subjects who can't stop drinking from 2 days before each measurement.
(4)Subjects who have declared allergic reaction to ingredients contained in test foods or loading foods.
(5) Subjects who contract or are under treatment for diseases (e.g., diabetes, liver disease, kidney disease, heart disease, respiratory disease, endocrine disease and/or metabolic disease).
(6)Subjects who have a history and/or a surgical history of digestive disease affecting digestion and absorption.
(7)Subjects who are judged unsuitable for the current study by the screening tests.
(8)Subjects who are diagnosed as anemic by the screening tests and unsuitable for frequent blood sampling.
(9) Subjects who have had diarrhea within the last one week prior to the screening tests.
(10)Subjects who have donated over 200 mL of blood and/or blood components within the last one month or over 400 mL of blood and/or blood components within the last three months prior to the current study.
(11)Subjects who are under treatment for or have a history of drug addiction and/or alcoholism.
(12) Subjects who are shiftworker and/or midnight-shift worker.
(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) Subjects who are planning to become pregnant after informed consent, pregnant or lactating.
(15) Subjects who are judged unsuitable for the current study by the investigator for other reasons.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Tokushima |
Organization
Maebashi North Hospital
Division name
Director
Zip code
371-0054
Address
692 Shimohosoi-machi,Maebashi-shi,Gumma
TEL
027-235-3333
sagawa@mc-connect.co.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
Sales department
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
yoshi@kso.co.jp
Sponsor or person
Institute
KSO Corporation
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
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joto-machi, Maebashi-shi, Gumma
Tel
027-212-5608
sagawa@mc-connect.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 | 07 | Month | 08 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000046828
Publication of results
Published
Result
URL related to results and publications
http://www.pieronline.jp/content/article/0386-3603/49020/321
Number of participants that the trial has enrolled
12
Results
Statistically significant difference was confirmed in the primary outcome.
Results date posted
| 2021 | Year | 10 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Males and females aged 20 to 64 years old.
Participant flow
Enrolled(n=12)
Completed(n=11)
Analysed(n=7)
Adverse events
No adverse events were observed that be related to test food.
Outcome measures
GLP-1
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 09 | Day |
Last follow-up date
| 2020 | Year | 08 | 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
| 2020 | Year | 07 | Month | 06 | Day |
Last modified on
| 2021 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046828
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
