UMIN-CTR Clinical Trial

Basic information
Public title	Study on the effects of research food intake on fatigue, sleep, and concentration.
Acronym	Study on the effects of research food intake on fatigue, sleep, and concentration.
Scientific Title	Study on the effects of research food intake on fatigue, sleep, and concentration.
Scientific Title:Acronym	Study on the effects of research food intake on fatigue, sleep, and concentration.
Region	Japan

Condition
Condition	Healthy adult (worker)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effects of QOL Bacillus subtilis subsp. natto-containing food on fatigue, sleep, and concentration after 8 weeks of continuous intake, using placebo as a control.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	(1) Athens Insomnia Scale (2) The Japanese version of the Pittsburgh Sleep Quality Index (3) OSA sleep inventory MA version Evaluate before ingestion and 4 to 8 weeks after ingestion.
Key secondary outcomes	(1) Salivary s-IgA secretion rate (2) Stress markers in the blood (DHEA-S, Cortisol) (3) POMS2 shortened version for adults (4) Fatigue VAS (5) Fatigue accumulation self-diagnosis checklist (6) Uchida-Kraepelin test (7) Purdue Pegboard Test Evaluate before ingestion and 4 to 8 weeks after ingestion.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	2 grains of the test product daily oral intake for 8 weeks.
Interventions/Control_2	2 grains of the placebo daily oral intake for 8 weeks.
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) Healthy worker between the ages of 20 and 64. (2) Subjects with a total score of 6 or more on the Pittsburgh questionnaire at the time of pre-examination.
Key exclusion criteria	(1) Subjects who routinely use food containing of abundant Bacillus natto, health foods, quasi-drugs, or drugs. (2) Subjects who act for the purpose of improving sleep, stress, fatigue (including hospital visits and treatment), and use medicines and health foods. (3) Night and day shift worker or manual laborer. (4) Subjects who have a disease that is being treated or who have a disease that is deemed to require treatment. (5) Subjects who are under treatment or have a history of serious diseases (e.g., diabetes, liver disease, kidney disease, or heart disease). (6) Subjects who are a history of mental illness (e.g., depression). (7) Subjects having possibilities for emerging allergy related to the study. (8) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire and other questionnaires. (9) Subjects who cannot carry out the procedures of various tests to be carried out during this study. (10) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination before intake. (11) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study. (12) Subjects who are planned to become pregnant or are pregnant or lactating. (13) Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Naoki Middle name Last name Nakamura
Organization	IKEDA FOOD RESEARCH CO.,LTD
Division name	Food Science and Technology Institute
Zip code	721-0956
Address	95-7, Minooki-cho, Fukuyama-city, Hiroshima, Japan
TEL	084-957-3411
Email	n.nakamura@ikedatohka.co.jp

Public contact
Name of contact person	1st name Shingo Middle name Last name Yamamichi
Organization	EP Mediate Co., Ltd.
Division name	Development Business Headquarters, TTC Center, Trial Planning Department
Zip code	162-0822
Address	Tsuruya Bldg., 2-23 Shimomiyabicho, Shinjuku-ku, Tokyo
TEL	03-5657-4983
Homepage URL
Email	yamamichi.shingo578@eps.co.jp

Sponsor
Institute	EP Mediate Co., Ltd.
Institute
Department

Funding Source
Organization	IKEDA FOOD RESEARCH 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	Medical Station Clinic Research Ethics Committee
Address	3-12-8, Takaban, Meguroku, Tokyo
Tel	03-6452-2712
Email	saito.teruo876@eps.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 07 Month 11 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	2021 Year 06 Month 24 Day
Date of IRB	2021 Year 06 Month 24 Day
Anticipated trial start date	2021 Year 07 Month 12 Day
Last follow-up date	2021 Year 12 Month 11 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 07 Month 08 Day
Last modified on	2022 Year 01 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051168