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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032114
Receipt No. R000036529
Scientific Title A Clinical Study for Evaluating the Safety of Excessive Consumption of Food containing Plant Extract -Open Study-
Date of disclosure of the study information 2018/04/05
Last modified on 2018/04/02

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Basic information
Public title A Clinical Study for Evaluating the Safety of Excessive Consumption of Food containing Plant Extract -Open Study-
Acronym A Clinical Study for Evaluating the Safety of Excessive Consumption of Food containing Plant Extract
Scientific Title A Clinical Study for Evaluating the Safety of Excessive Consumption of Food containing Plant Extract -Open Study-
Scientific Title:Acronym A Clinical Study for Evaluating the Safety of Excessive Consumption of Food containing Plant Extract
Region
Japan

Condition
Condition No
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
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Doctor's questions, Physical measurement, Physical examination, Blood test (Hematological test, Blood biochemical test, Serum-immunological test), Urinalysis, Adverse event
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 Foods 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) Healthy males and females aged 20 to 64 years-old.
(2) Subjects whose LDL-cholesterol levels are under 140 mg/dL.
(3) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria (1) Subjects who were diagnosed with serious disease (e.g., diabetes, liver disease, kidney disease, digestive disease, heart disease, respiratory disease and/or peripheral vascular disease).
(2) Subjects with abnormal parameters in blood lipids, liver and/or kidney function.
(3) Subjects who had a gastrointestinal surgery.
(4) Subjects with a disease currently under treatment.
(5) Subjects with drug or food allergies.
(6) Subjects who play high intensity sports and/or are on a diet.
(7) Subjects with irregular life patterns.
(8) Subjects who can't stop using functional foods (including Food for Specified Health Uses or Foods with Function Claims) and/or Specified quasi-drugs during the current study periods.
(9) Subjects who are under treatment with medications (including OTC or prescribed medication).
(10) Subjects who drink excessive alcohol, or who can't stop drinking from one day before each measurement.
(11) Subjects who are planning to become pregnant after informed consent for the current study, pregnant or lactating.
(12) Subjects who are participating in other studies or planning to participate during the current study period.
(13) Subjects who are judged as unsuitable for the current study 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
2018 Year 04 Month 05 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
2018 Year 03 Month 13 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 09 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
2018 Year 04 Month 05 Day
Last modified on
2018 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036529

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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