UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055078 |
|---|---|
| Receipt number | R000062565 |
| Scientific Title | Evaluation of the Effects of Test Food Consumption on Performance |
| Date of disclosure of the study information | 2025/07/26 |
| Last modified on | 2025/03/24 19:58:56 |
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Basic information
Public title
Evaluation of the Effects of Test Food Consumption on Performance
Acronym
Evaluation of the Effects of Test Food Consumption on Performance
Scientific Title
Evaluation of the Effects of Test Food Consumption on Performance
Scientific Title:Acronym
Evaluation of the Effects of Test Food Consumption on Performance
Region
| Japan |
Condition
Condition
Male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To scientifically evaluate the effects of test food consumption on performance in study subjects aged 25 to 49 years who have poor sleep quality and persistent physical fatigue.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective Mood Questionnaire
Key secondary outcomes
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
Consumption of the test food (3 tablets a day) for 8 weeks
Interventions/Control_2
Consumption of the placebo food (3 tablets a day) 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
| 25 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Men and women aged 25 to 49 years at the time of consent.
2. Subjects who have a habit of exercising for more than 5 hours per week.
3. Subjects who have perceived poor sleep quality for more than one month prior to consent acquisition.
4. Subjects who have perceived physical fatigue for more than one month prior to consent acquisition.
5. Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria
1. Subjects currently undergoing medication or outpatient treatment for any serious disease, or those with a history of serious disease.
2. Subjects who cannot maintain their exercise habits and dietary habits from before the study during the trial period.
3. Subjects who are prone to diarrhea or have a weak stomach when consuming dairy products or foods containing lactic acid bacteria in excess.
4. Subjects with extremely irregular lifestyle habits, such as diet and sleep.
5. Subjects who are participating in the other clinical trials and/or who have participated in the other clinical trials within 4 weeks prior to the current trial and/or who are planning to participate in the other clinical trials.
6. Females who are pregnant or lactating, and females who could become pregnant during trial period.
7. Subjects with allergies to medications and/or food.
8. Subjects deemed unsuitable for participation in the trial by the study representative or the principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Asahi Quality & Innovations, 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.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
| 2025 | Year | 07 | Month | 26 | 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
| 2024 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 26 | Day |
Last modified on
| 2025 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062565
