UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026962
Receipt No. R000029972
Scientific Title A Study to Evaluate the Safety of Excessive Consumption of Food Containing Plant Extract.
Date of disclosure of the study information 2017/04/15
Last modified on 2019/02/13

* 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 to Evaluate the Safety of Excessive Consumption of Food Containing Plant Extract.
Acronym A Study to Evaluate the Safety of Excessive Consumption of Food Containing Plant Extract.
Scientific Title A Study to Evaluate the Safety of Excessive Consumption of Food Containing Plant Extract.
Scientific Title:Acronym A Study to Evaluate the Safety of Excessive Consumption of Food Containing Plant Extract.
Region
Japan

Condition
Condition Healthy Adult (including borderline diabetes)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety of excessive consumption of food containing plant extract for 4 weeks in healthy adults.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Inquiry, physical examination, medical examination by hematology,blood biochemistry, urinalysis.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Test food containing plant extract, 4 weeks excessive consumption.
Interventions/Control_2
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
64 years-old >=
Gender Male and Female
Key inclusion criteria (1) 20<=Age=<64 of healty men and women
(2) Subjects who are judged as normoglycemic or borderline diabetes by the investigator
(3) Subjects who can make self-judgments and voluntarily give written informed consents
Key exclusion criteria (1) Subjects with a medical history of diabetes, liver disease, kidney disease, gastrointestinal disease, peripheral vascular disease, or severe diseases
(2) Subjects with a disorder in heart and lung function
(3) Subjects with abnormal parameters in liver or kidney function
(4) Subjects who had a gastrointestinal surgery
(5) Subjects with a disease currently under treatment
(6) Subjects with drug or food allergies
(7) Subjects with anemic
(8) Subjects who play high intensity sports or are on a diet
(9) Subjects who are taking supplemental foods, quasi drugs or drug products (including OTC or prescribed medication) containing ingredient of test food
(10) Subjects who drink excessive alcohol, or who cannot stop drinking alcohol at one day prior to the test day and the day of the test
(11) Subjects who have been pregnant or subjects who have a plan to become pregnant or breast feed during the study period
(12) Subjects who is participating in other studies or planning to participate during the study period
(13) Subjects who are deemed unsuitable by the investigator for other reasons
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Miura
Organization Miura Clinic, Medical Corporation Kanonkai
Division name Internal Medicine
Zip code
Address Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL 06-6135-5200
Email tterashima@miula.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Terashima
Organization Oneness support Co., Ltd.
Division name Clinical trial Division
Zip code
Address Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL 06-4801-8917
Homepage URL
Email mterashima@oneness-sup.co.jp

Sponsor
Institute Oneness support Co., Ltd.
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
Address
Tel
Email

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
2017 Year 04 Month 15 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 Completed
Date of protocol fixation
2017 Year 02 Month 17 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 17 Day
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
2017 Year 04 Month 12 Day
Last modified on
2019 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029972

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.