UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060674 |
|---|---|
| Receipt number | R000069397 |
| Scientific Title | Effect of test foods Intake on Fatigue, Sleepiness, and Core Body Temperature (Study 2) |
| Date of disclosure of the study information | 2026/02/14 |
| Last modified on | 2026/02/14 10:47:17 |
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Basic information
Public title
Effect of test foods Intake on Fatigue, Sleepiness, and Core Body Temperature (Study 2)
Acronym
Effect of test foods Intake on Fatigue, Sleepiness, and Core Body Temperature (Study 2)
Scientific Title
Effect of test foods Intake on Fatigue, Sleepiness, and Core Body Temperature (Study 2)
Scientific Title:Acronym
Effect of test foods Intake on Fatigue, Sleepiness, and Core Body Temperature (Study 2)
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study compares fatigue, drowsiness, and core body temperature following a single intake of test food as a placebo control.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Deep body temperature,VAS (fatigue, sleepiness)
Key secondary outcomes
Core surface temperature, peripheral body temperature, VAS (satiety, cold sensation)
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food C (single serving) - washout period - (single serving)- placebo D (single serving)
Interventions/Control_2
Intake of placebo D (single serving) - washout period - test food C (single serving)
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy males and females from 20 to 70 years of age.
(2) Subjects who fully understand the purpose and content of this study and voluntarily agree to participate in the study.
Key exclusion criteria
(1) Subjects who regularly consume foods containing test food ingredients.
(2) Subjects who are currently consuming health foods such as foods for health uses or foods with functional claims and cannot discontinue them during participation in this trial.
(3) Subjects who may be at risk of developing allergies in relation to the research.
(4) Subjects with a history of treatment for malignant tumors, heart failure, or myocardial infarction.
(5) Individuals undergoing treatment for chronic diseases or with a medical history.
Arrhythmia, liver dysfunction, kidney dysfunction, cerebrovascular disease, rheumatism, diabetes, dyslipidemia, hypertension, other chronic diseases.
(6) Subjects who require regular medication, those currently undergoing treatment for a disease, and those with a history of severe diseases that required medication treatment.
(7) Subjects with pacemakers or other implantable medical devices.
(8) Subjects unable to attach devices for core body temperature measurement (chest) and peripheral temperature measurement (back of the hand), and perform tests according to procedure.hand).
(9) Subjects Subjects who are judged to be unsuitable for participation in the study based on their responses to the or pre-intak..
(10) Subjects who work in shifts, night shifts, or have irregular daily schedules.
(11) Subjects who participated in other clinical studies during the one-month period prior to study enrollment (pre-screening).
(12) Subjects who are pregnant, breastfeeding, or plan to become pregnant or breastfeed during the study period.
(13) Subjects who are judged to be unsuitable as subjects based on the answers to the background survey.
(14) Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Miyuki |
| Middle name | |
| Last name | Watanabe |
Organization
Chusei oil Co., Ltd.
Division name
Research and Development Group
Zip code
713-8103
Address
8252-8 Tamashimaotoshima Kurashiki-shi,Okayama
TEL
086-526-1106
m.watanabe@chusei-oil.co.jp
Public contact
Name of contact person
| 1st name | Chiharu |
| Middle name | |
| Last name | Goto |
Organization
EP Mediate Co., Ltd.
Division name
Development Department Trial Planning Section
Zip code
162-0814
Address
Acropolis Tokyo, 6-29 Shinogawacho, Shinjuku, Tokyo
TEL
090-1536-4583
Homepage URL
goto.chiharu069@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Chusei oil 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
Medical Station Clinic Research Ethics Committee
Tel
03-6452-2712
epmd_fd-erb@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
メディカルステーションクリニック (Medical station clinic) (東京都)、DRC東京評価センター（DRC Co., Ltd. Tokyo evaluation center）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 14 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 14 | Day |
Last modified on
| 2026 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069397
