UMIN-CTR Clinical Trial

Basic information
Public title	Verification of emission effects of hazardous substances by ingestion of test foods
Acronym	Verification of emission effects of hazardous substances by ingestion of test foods
Scientific Title	Verification of emission effects of hazardous substances by ingestion of test foods
Scientific Title:Acronym	Verification of emission effects of hazardous substances by ingestion of test foods
Region	Japan

Condition
Condition	Healthy individuals
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Healthy adult men and women will be given the test food continuously for 24 weeks to see how it affects the elimination of harmful substances in the body and to test its potential for detoxification.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Urine test (TOX test), Mycotoxin, heavy metal test, organic acid test
Key secondary outcomes	Hematological tests, blood biochemistry tests, urinalysis, subjective quality of life questionnaires

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	Oral consumption of the test food for 24 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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1) Men and women between 20 and 64 years of age 2) Applicants who have a thorough understanding of the purpose and content of the examination and who have volunteered freely and agreed to participate in the examination in writing
Key exclusion criteria	1) Those with serious diseases of the liver, kidney, heart, lung, digestive system, blood, endocrine system, and metabolic system 2) Those who have a disease requiring regular medication or a history of a serious disease requiring medication treatment 3) Those with a BMI of 26 or more 4) A person who regularly uses functional foods and supplements that may affect the discharge of hazardous substances 5) Those whose working hours are irregular due to night shift or irregular work 6) A person who smokes excessively or is a regular user of alcohol 7) Those whose lifestyle habits, such as eating and sleeping, are extremely irregular 8) Those who have donated blood within 4 weeks before obtaining consent 9) A person who has a history of hypersensitivity to test food ingredients 10) Those who are pregnant, lactating, or who intend to become pregnant during the examination period 11) Those who are participated in other clinical trials and monitored studies within one month prior to obtaining consent 12) Any other person deemed unsuitable as a subject by the study physician or study assignment physician
Target sample size	5

Research contact person
Name of lead principal investigator	1st name Ayaka Middle name Last name Nakashima
Organization	euglena Co., Ltd.
Division name	R&D department Functionality Research Section
Zip code	108-0014
Address	Shiba 5-29-11 Minato-ku, Toyko 108-0014, Japan
TEL	03-3453-4907
Email	nakashima@euglena.jp

Public contact
Name of contact person	1st name Ayaka Middle name Last name Nakashima
Organization	euglena Co., Ltd.
Division name	R&D department Functionality Research Section
Zip code	108-0014
Address	Shiba 5-29-11 Minato-ku, Toyko 108-0014, Japan
TEL	03-3453-4907
Homepage URL
Email	nakashima@euglena.jp

Sponsor
Institute	Square Clinic
Institute
Department

Funding Source
Organization	euglena 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	Japan Conference of Clinical Research
Address	1-13-23 Minamiikebukuro, Toshima-Ku, Tokyo, Japan
Tel	03-6869-2920
Email	nakashima@euglena.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	スクエアクリニック（神奈川県）

Other administrative information
Date of disclosure of the study information	2020 Year 12 Month 25 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	5
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	No longer recruiting
Date of protocol fixation	2020 Year 01 Month 17 Day
Date of IRB	2020 Year 01 Month 17 Day
Anticipated trial start date	2020 Year 01 Month 27 Day
Last follow-up date	2020 Year 11 Month 09 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 05 Month 18 Day
Last modified on	2020 Year 05 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046144