UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044803 |
|---|---|
| Receipt number | R000051168 |
| Scientific Title | Study on the effects of research food intake on fatigue, sleep, and concentration. |
| Date of disclosure of the study information | 2021/07/11 |
| Last modified on | 2022/01/06 09:12:42 |
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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
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
yamamichi.shingo578@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051168
