UMIN-CTR Clinical Trial

Basic information
Public title	A verification study for the efficacy of SBL88TM intake on improving task performance
Acronym	A verification study for the efficacy of SBL88TM intake on improving task performance
Scientific Title	A verification study for the efficacy of SBL88TM intake on improving task performance: an open-label trial
Scientific Title:Acronym	A verification study for the efficacy of SBL88TM intake on improving task performance
Region	Japan

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

Objectives
Narrative objectives1	To investigate the efficacy of SBL88TM intake on improving task performance
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1. The measured values on scores for each category of OSA sleep inventory MA version (OSA-MA; five categories) at four weeks after the start of test-food consumption (4w) 2. The measured values on scores for each item of OSA-MA (16 items) at 4w 3. The measured values of subjective symptom scores based on the VAS item scores at 4w 4. The measured values of work efficiency test (Advanced Trail Making Test; ATMT) at 4w
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	Treatment
Type of intervention	Food
Interventions/Control_1	<Group1> Duration: 2 weeks Test food: SBL88TM sterilized lactic acid bacterial cells 25 mg (2.5 x 1010cells) Administration: One tablet per day at any time during the day <Group2> Duration: 4 weeks Test food: SBL88TM sterilized lactic acid bacterial cells 25 mg (2.5 x 1010cells) Administration: One tablet per day at any time during the day <Group3> Duration: 4 weeks Test food: SBL88TM sterilized lactic acid bacterial cells 25 mg (2.5 x 1010cells) Administration: One tablet per day at any time during the day
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Subjects who are affiliated with Sapporo Group or ORTHOMEDICO Inc. 2. Healthy Japanese adult subjects 3. Subjects who are judged as eligible to participate in the trial by the physician 4. Subjects who can participate in the trial according to the schedule 5. Subjects who voluntary give their consent to participate in the trial
Key exclusion criteria	1. Subjects undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction 2. Subjects carrying a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, sleep apnea syndrome, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage as part of their daily intake 5. Subjects regularly taking medications (including herbal medicines) and supplements 6. Subjects allergic to medications and/or the test-food-related products 7. Subjects who are pregnant, lactating, or intending to become pregnant 8. Subjects who live with their infants less than 1 year old 9. Subjects who co-sleep with their children (1 to 6 years old) 10. Subjects who live with requiring long-term care persons 11. Subjects who share the bed with more than one person 12. Subjects who work late-night shift and the life-styles are irregular 13. Subjects who wake up for urination three times or more during nocturnal sleep 14. Subjects whose dinner time is extremely irregular 15. Subjects who are troubled with pollen allergy or asthma 16. Subjects who drink alcohol heavily 17. Subjects who have been enrolled in other clinical trials within the last three months before the invitation to participate in this trial, or plan to participate in another trial during this trial 18. Subjects who are judged by the physician as ineligible to participate in the trial
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Kazuo Middle name Last name YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	CEO
Zip code	112-0002
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Email	kazu@orthomedico.jp

Public contact
Name of contact person	1st name Naoko Middle name Last name SUZUKI
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Zip code	112-0002
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	SAPPORO WELLNESS LAB LIMITED
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address	9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel	03-5793-3623
Email	info@takara-clinic.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	医療法人社団盛心会 タカラクリニック (東京都) Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information	2019 Year 11 Month 07 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	80
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 10 Month 25 Day
Date of IRB	2019 Year 10 Month 25 Day
Anticipated trial start date	2019 Year 11 Month 08 Day
Last follow-up date	2019 Year 12 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 11 Month 06 Day
Last modified on	2020 Year 02 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043815