UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059303 |
|---|---|
| Receipt number | R000067834 |
| Scientific Title | Effects of test food consumption on subjective fatigue in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2025/10/06 |
| Last modified on | 2025/10/06 12:08:55 |
* 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
Effects of test food consumption on subjective fatigue in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Acronym
Effects of test food consumption on subjective fatigue in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title
Effects of test food consumption on subjective fatigue in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
Effects of test food consumption on subjective fatigue in healthy Japanese
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of test food consumption on subjective fatigue in healthy Japanese.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The measured value of fatigue measured by Visual Analogue Scale (VAS) at 12 weeks after intervention (12w) [before and after workload: change from before workload to after workload]
Key secondary outcomes
1. The change and percentage change in fatigue (VAS) from screening at 12w [before and after workload]
2. The measured value of fatigue (VAS) at 12w, and the change and percentage change from screening [before workload and after workload]
3. The measured values of Total Mood Disturbance score (TMD), Anger-Hostility (AH), Confusion-Bewilderment (CB), Depression-Dejection (DD), Fatigue-Inertia (FI), Tension-Anxiety (TA), Vigor-Activity (VA), and Friendliness (F) in the Profile of Mood States 2nd Edition (POMS2) at 12w [before workload]
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test product: Squalene capsule
Interventions/Control_2
Duration: 12 weeks
Test product: Placebo capsule
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Adults
4. Healthy individuals
5. Individuals who experience temporary fatigue in daily life
6. Individuals who are judged by the physician to have no issues with study participation based on the results of the Beck Depression Inventory-Second Edition (BDI-II) at screening
7. Individuals with a large positive fatigue (VAS) value at screening, calculated as after workload minus before workload
Key exclusion criteria
Individuals who
1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
2. have a pacemaker or an implantable cardioverter defibrillator
3. are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
5. are taking or using medicines (including herbal medicines) or supplements
6. are allergic to medicines or foods related to the test product (particularly fish or gelatin)
7. are pregnant, lactating, or planning to become pregnant during this study
8. have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study
9. have mental health issues such as depression disorder or attention deficit/hyperactivity disorder
10. are undergoing medical treatment or have a medical history of chronic fatigue syndrome
11. have irregular working patterns, including those involving night shifts
12. work in physical labor such as transportation of heavy objects
13. have irregular lifestyles (whose habits vary every day such as dietary habits, exercise habits, and sleeping habits)
14. consume alcohol in excess daily
15. consume foods containing ingredients that may affect fatigue or stress (e.g., S-allylcysteine, gamma-aminobutyric acid, lactic acid bacteria, reduced Coenzyme Q10, Euglena gracilis-derived paramylon, docosahexaenoic acid, eicosapentaenoic acid, astaxanthin, citric acid, L-Theanine, black soybean polyphenols, 5-aminolevulinic acid phosphate, anserine)
16. are judged as ineligible to participate in this study by the physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
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
nao@orthomedico.jp
Sponsor or person
Institute
ORIHIRO Plantdew Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
ORIHIRO Plantdew 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
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@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)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 17 | 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 | 10 | Month | 06 | Day |
Last modified on
| 2025 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067834
