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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041013
Receipt No. 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 2020/07/06

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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
Email 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
Email yoshi@kso.co.jp

Sponsor
Institute KSO Corporation
Institute
Department

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
Email 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
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 Preinitiation
Date of protocol fixation
2020 Year 06 Month 24 Day
Date of IRB
Anticipated trial start date
2020 Year 07 Month 09 Day
Last follow-up date
2020 Year 09 Month 30 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
2020 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.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


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