UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043616
Receipt No. R000049802
Scientific Title A study for safety of excessive intake of supplements Open-label study
Date of disclosure of the study information 2021/03/15
Last modified on 2021/03/15

* 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 for safety of excessive intake of supplements
Open-label study
Acronym A study for safety of excessive intake of supplements
Scientific Title A study for safety of excessive intake of supplements
Open-label study
Scientific Title:Acronym A study for safety of excessive intake of supplements
Region
Japan

Condition
Condition healthy individuals
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate safety by overdose (triple) the test food to the subject.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Adverse event
Physical examination
Hematological test
Blood biochemical test
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 Ingestion of test food for 4 weeks
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) Subjects of men and women aged 20 to 64
(2) Subjects with a BMI of less than 30 kg / m2
(3) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing.
Key exclusion criteria (1) Persons with a history of liver disease, renal disease, digestive system disease, heart disease, diabetes, or other diseases that may affect the results of this study, or subjects with a history of surgery
(2) Subjects with abnormal liver function and renal function test values
(3) Subjects with diseases currently being treated
(4) Subjects with food and drug allergies
(5) Subjects with anemia symptoms
(6) Subjects who play intense sports and subjects who are on a diet
(7) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period
(8) Subjects who are continuously treated with medicines (including OTC and prescription drugs)
(9) Subjects who are excessively ingesting alcohol
(10) Subjects who cannot stop drinking from the day before the test to the day of the test
(11) Pregnant subjects or subjects who are planning to become pregnant or breastfeed during the test period
(12) Subjects who are participating in or will participate in other clinical trials at the start of this study.
(13) Other subjects judged by the investigator to be inappropriate
Target sample size 15

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 buildng 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL 0661355200
Email info@miura-cl.jp

Public contact
Name of contact person
1st name Makoto
Middle name
Last name Terashima
Organization Oneness Support Co., Ltd.
Division name Clinical Trial Division
Zip code 530-0044
Address Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL 0648018917
Homepage URL
Email mterashima@oneness-sup.co.jp

Sponsor
Institute Miura Clinic, Medical Corporation Kanonkai
Institute
Department

Funding Source
Organization Kantoshimbunhanbai Inc.
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 Miura Clinic, Medical Corporation Kanonkai IRB
Address Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
Tel 0661355200
Email mterashima@oneness-sup.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
2021 Year 03 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 Preinitiation
Date of protocol fixation
2021 Year 02 Month 15 Day
Date of IRB
Anticipated trial start date
2021 Year 03 Month 24 Day
Last follow-up date
2021 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 03 Month 15 Day
Last modified on
2021 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049802

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.