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 UMIN000034658
Receipt No. R000039513
Scientific Title A safety evaluation study of excessive intake of the test food (HBF2018-02).
Date of disclosure of the study information 2018/10/28
Last modified on 2019/09/17

* 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 safety evaluation study of excessive intake of the test food (HBF2018-02).
Acronym A safety evaluation study of excessive intake of the test food.
Scientific Title A safety evaluation study of excessive intake of the test food (HBF2018-02).
Scientific Title:Acronym A safety evaluation study of excessive intake of the test food.
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety of the test food.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

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

Base
Study type Interventional

Study design
Basic design Parallel
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 Prevention
Type of intervention
Food
Interventions/Control_1 Four-week repeated intake of food containing the test food.
Interventions/Control_2 Four-week repeated intake of control food not containing the test food.
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 can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria 1)Subjects with hepatic, renal, cardiac and/or organ disorders, diabetes, and/or other serious diseases.
2)Subjects with present heart disorder, liver disorder, and/or kidney disorder.
3)Subjects with a disease currently under treatment.
4)Subjects with allergy to the study foods.
5)Subjects with anemia.
6)Subjects who play high intensity sports and/or are on a diet.
7)Subjects who play high intensity sports and/or are on a diet.
8)Subjects who are under treatment with medications (including OTC or prescribed medication).
9)Subjects who drink excessive alcohol, and/or who can't stop drinking from one day before each measurement.
10)Individuals who are a smoker.
11)Subjects who are pregnant, breast-feeding, and/or planning to become pregnant
12)Subjects who are participating in other studies and/or planning to participate during the current study period.
13)Subjects judged as unsuitable for the study by principal investigator for other reasons.
Target sample size 44

Research contact person
Name of lead principal investigator
1st name Naoki
Middle name
Last name Miura
Organization Miura Clinic, Medical Corporation Kanonkai
Division name Internal Medicine
Zip code 530-0044
Address Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL 06-6135-5200
Email info@miula.co.jp

Public contact
Name of contact person
1st name Yuki
Middle name
Last name Ishida
Organization Hayashibara CO., LTD.
Division name R & D Division, Food Materials Unit
Zip code 702-8006
Address 675-1, Fujisaki, Naka-ku, Okayama
TEL 086-276-3141
Homepage URL
Email yuki.ishida@hb.nagase.co.jp

Sponsor
Institute Oneness Support Co., Ltd.
Institute
Department

Funding Source
Organization Hayashibara 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 The Ethics Committee of Miura Clinic, Medical Corporation Kanonkai
Address Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
Tel 06-6135-5200
Email 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 医療法人花音会みうらクリニック(大阪府) / Miura Clinic, Medical Corporation Kanonkai (Osaka)

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 28 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 44
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
2018 Year 09 Month 19 Day
Date of IRB
2018 Year 09 Month 20 Day
Anticipated trial start date
2018 Year 10 Month 28 Day
Last follow-up date
2019 Year 01 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 26 Day
Last modified on
2019 Year 09 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039513

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.