UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056951 |
|---|---|
| Receipt number | R000065081 |
| Scientific Title | Study of Combined Effectiveness of Fatigue Amelioration Techniques_g2024008 |
| Date of disclosure of the study information | 2025/02/21 |
| Last modified on | 2026/02/16 17:34:08 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Fatigue improvement effect study
Acronym
Fatigue improvement effect study
Scientific Title
Study of Combined Effectiveness of Fatigue Amelioration Techniques_g2024008
Scientific Title:Acronym
Fatigue improvement effect study
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of the simultaneous and continuous use of multiple fatigue-improving technologies on subjective fatigue and the biological changes occurring in the background.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of change in fatigue VAS
Key secondary outcomes
Questionnaires such as the OSA (Onset Sleep Assessment)
Autonomic nervous system status by heart rate variability analysis, blood pressure, etc.
Measurements of mental alertness
Sleep state (sleep latency, mid-awake, heart rate on awakening, resting heart rate)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food | Other |
Interventions/Control_1
Provide sleep hygiene information
Interventions/Control_2
Consumption of test product A (food) and use of test product B and specific exercises for 6 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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Male and female aged 20-59
2. Persons who feel fatigue on a daily basis
3. Persons who agree to use the wearable device (Fitbit), install the Fitbit application on their smartphone, and create a Google account for the study.
Key exclusion criteria
1. Person who has suffer from chronic diseases currently (diabetes, hypertension, hyperlipidemia, gout, kidney disease, rheumatism, respiratory disease, etc.) and are taking medication. (however, users of drugs that suppress allergic symptoms such as allergic rhinitis can be included in the subjects)
2. Person who has difficulty participating in research due to liver, kidney, heart disease, respiratory disorder, endocrine disorder, metabolic disorder, neurological disorder, consciousness disorder, diabetes, or other diseases.
3. Person diagnosed with insomnia, sleep apnea, or other sleep disorders
4. Person diagnosed with chronic fatigue syndrome
5. Person taking sleeping pills
6. Person who with alcoholic drinkers. (alcohol equivalent 60g / day or more) : (Beer: 3 medium bottles (1.5L), Sake: 3 go (540ml), Whiskey: 3 double glasses (180ml), Shochu: 1.8go (330ml) or more)
7. Person who plans to participate in other clinical trials during the trial participation period.
8. Currently pregnant or intending to become pregnant during the period of study participation.
9. Person who has a history of drug dependence, alcohol dependence, or current medical history.
10. Person who plans to travel, go on business, or vacation for more than 4 consecutive days during the measurement period.
11. Person working in shifts and night shifts
12. Person with injuries or pain that affect normal walking
13. Person who is allergic to any of the ingredients in the test food.
14. Person who is prone to skin irritation from adhesive tapes and other products that stick to the skin.
15. Person who may not be able to consume ingredients whose origin is not specified in the test food due to religious or other reasons.
16. Person who is planning to undergo a major life change such as going to school, getting a job, or moving during the measurement period.
17. Person who has deemed inappropriate to participate in this study by the principle investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Minegishi |
Organization
Kao Corporation
Division name
Human Health Care Products Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7268
minegishi.yoshihiko@kao.com
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Hasumura |
Organization
Kao Corporation
Division name
Human Health Care Products Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7268
Homepage URL
hasumura.takahiro@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.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
| 2025 | Year | 02 | Month | 21 | 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
75
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
| 2025 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 06 | Day |
Last modified on
| 2026 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065081
