UMIN-CTR Clinical Trial

Basic information
Public title	A study to investigate the efficacy and dose response of Euglena by questionnaires for a measure of the subjective well-being
Acronym	A study to investigate the efficacy and dose response of Euglena by questionnaires for a measure of the subjective well-being
Scientific Title	A study to investigate the efficacy and dose response of Euglena by questionnaires for a measure of the subjective well-being
Scientific Title:Acronym	A study to investigate the efficacy and dose response of Euglena by questionnaires for a measure of the subjective well-being
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study is to evaluate the dose response of Euglena for improving subjective well-being depending on the amount of Euglena intake.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Questionnaires for subjective well-being or other QOL scales
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	Dose comparison
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking
Concealment	No need to know

Intervention
No. of arms	7
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of study food (containing related ingredients 500mg ) for 4 weeks
Interventions/Control_2	Ingestion of study food (containing related ingredients 700mg ) for 4 weeks
Interventions/Control_3	Ingestion of study food (containing related ingredients 1,000mg ) for 4 weeks
Interventions/Control_4	Ingestion of study food (containing related ingredients 1,500mg ) for 4 weeks
Interventions/Control_5	Ingestion of study food (containing related ingredients 2,000mg ) for 4 weeks
Interventions/Control_6	Ingestion of study food (containing related ingredients 3,000mg ) for 4 weeks
Interventions/Control_7	Ingestion of control food substance for 4 weeks
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)Subjects of both sexes above 20 years old- under 65 years old 2)Subjects who can answer on line questionnaires by smartphone or iPhone 3)Subjects who give consent
Key exclusion criteria	1)Subjects who are under pharmacological treatment for chronic disorders, especially subjects who take Warfarin 2)Subjects who have histories of mental disorders (Depression etc.) 3)Subjects work irregular hours on the night shift or irregular shift 4)Subjects who had participated in other clinical trials or monitoring studies within 1 month 5)Subjects who have intolerance to study food substance 6)Subjects who are in pregnancy, lactation, or who are willing to become pregnant 7)Subjects who are ineligible due to the chief inspector's judgment
Target sample size	210

Research contact person
Name of lead principal investigator	1st name Ayaka Middle name Last name Nakashima
Organization	euglena Co., Ltd.
Division name	Advanced Technology Research 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 shigeru Middle name Last name imai
Organization	Leverage Brain Inc.
Division name	Clinical Trial Department
Zip code	153-0053
Address	Gohongi 3-13-16 Meguro-ku, Tokyo 153-0053, Japan
TEL	08072900404
Homepage URL	https://www.levbrain.com
Email	imai@levbrain.com

Sponsor
Institute	Leverage Brain Inc.
Institute
Department

Funding Source
Organization	euglena Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Japan Conference of Clinical Research
Address	2-27-17 Minamiikebukuro Toshima-ku, Tokyo, Japan
Tel	0368687022
Email	jccr-info@cts-smo.com

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	2019 Year 07 Month 03 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	2019 Year 06 Month 03 Day
Date of IRB	2019 Year 06 Month 14 Day
Anticipated trial start date	2019 Year 07 Month 03 Day
Last follow-up date	2019 Year 09 Month 30 Day
Date of closure to data entry	2019 Year 10 Month 10 Day
Date trial data considered complete	2019 Year 10 Month 15 Day
Date analysis concluded	2019 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 06 Month 27 Day
Last modified on	2019 Year 11 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042408