UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the effects and timing of Test Diet intake on the subjective well-being bodily
Acronym	Examination of the effects and timing of Test Diet intake on the subjective well-being bodily
Scientific Title	Examination of the effects and timing of Test Diet intake on the subjective well-being bodily
Scientific Title:Acronym	Examination of the effects and timing of Test Diet intake on the subjective well-being bodily
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 examine the effects and timing of Test Diet intake on subjective well being
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	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking
Concealment	No need to know

Intervention
No. of arms	4
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	1.take an Active Test Diet containing 1,000mg Functional substance after breakfast, and take a placebo after dinner (After intake for 2 weeks, 2 weeks interval) 2.take a placebo after breakfast, and take an Active Test Diet containing 1,000mg Functional substance after dinner (After intake for 2 weeks, 2 weeks interval) 3.take an Active Test Diet containing 500mg Functional substance after breakfast and dinner (After intake for 2 weeks, 2 weeks interval) 4.take a placebo after breakfast and dinner (Intake for 2 weeks)
Interventions/Control_2	1.take a placebo food after breakfast and dinner (After intake for 2 weeks, 2 weeks interval) 2.take an Active Test Diet containing 1,000mg Functional substance after breakfast, and take a placebo after dinner (After intake for 2 weeks, 2 weeks interval) 3.take a placebo after breakfast, and take an Active Test Diet containing 1,000mg Functional substance after dinner (After intake for 2 weeks, 2 weeks interval) 4.take an Active Test Diet containing 500mg Functional substance after breakfast and dinner (Intake for 2 weeks)
Interventions/Control_3	1.take an Active Test Diet containing 500mg Functional substance after breakfast and dinner (After intake for 2 weeks, 2 weeks interval) 2.take a placebo after breakfast and dinner (After intake for 2 weeks, 2 weeks interval) 3.take an Active Test Diet containing 1,000mg Functional substance after breakfast, and take a placebo after dinner (After intake for 2 weeks, 2 weeks interval) 4.take a placebo after breakfast, and take an Active Test Diet containing 1,000mg Functional substance after dinner (Intake for 2 weeks)
Interventions/Control_4	1.take a placebo after breakfast, and take an Active Test Diet containing 1,000mg Functional substance after dinner (After intake for 2 weeks, 2 weeks interval) 2.take an Active Test Diet containing 500mg Functional substance after breakfast and dinner (After intake for 2 weeks, 2 weeks interval) 3.take a placebo after breakfast and dinner (After intake for 2 weeks, 2 weeks interval) 4.take an Active Test Diet containing 1,000mg Functional substance after breakfast, and take a placebo after dinner (Intake for 2 weeks)
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)Subjects of both sexes above 20 years old- under 65 years old 2)Subjects who can answer on-line questionnaire 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 who 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	36

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	105-0004
Address	Shinbashi 2-16-1 Minato-ku, Tokyo 105-0004, Japan
TEL	080-7290-0404
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

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	03-6868-7022
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	2020 Year 03 Month 22 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	36
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	2020 Year 02 Month 10 Day
Date of IRB	2020 Year 02 Month 21 Day
Anticipated trial start date	2020 Year 03 Month 23 Day
Last follow-up date	2020 Year 08 Month 02 Day
Date of closure to data entry	2020 Year 08 Month 10 Day
Date trial data considered complete	2020 Year 08 Month 31 Day
Date analysis concluded	2020 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date	2020 Year 03 Month 02 Day
Last modified on	2020 Year 09 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045238