UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059773 |
|---|---|
| Receipt number | R000067801 |
| Scientific Title | A Study on the Effects of Continuous Intake of a Food Product on Physical and Mental Health |
| Date of disclosure of the study information | 2025/11/14 |
| Last modified on | 2025/11/11 20:03:09 |
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Basic information
Public title
A Study on the Effects of Continuous Intake of a Food Product on Physical and Mental Health
Acronym
A Study on the Effects of Continuous Intake of a Food Product on Physical and Mental Health
Scientific Title
A Study on the Effects of Continuous Intake of a Food Product on Physical and Mental Health
Scientific Title:Acronym
A Study on the Effects of Continuous Intake of a Food Product on Physical and Mental Health
Region
| Japan |
Condition
Condition
Healthy adult male
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effects of continuous intake of the test food on physical and mental health.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood Metabolomics
Key secondary outcomes
Daily log (frequency of bowel movements, stool characteristics), Profile of mood states 2nd edition, VAS (Visual Analog Scale) questionnaire, Lifestyle questionnaire, PSQI (Pittsburgh Sleep Quality Index), SWLS (Satisfaction with Life Scale) (Japanese version), Hematological tests, Blood biochemical tests, Salivary cortisol, Salivary serotonin, Salivary oxytocin, Stratum corneum water content, Transepidermal water loss (TEWL), Skin viscoelasticity, Gut microbiota, Fecal short-chain fatty acids (SCFAs), Blood BDNF (Brain-derived neurotrophic factor)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral consumption of the test food (4 pieces per time, twice daily) for 4 weeks
Interventions/Control_2
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
| 30 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
1. Healthy males aged 30 to below 40 years at the time of consent acquisition.
2. Individuals with a body mass index (BMI) of 18.5 kg/m2 or higher and less than 25.0 kg/m2.
3. Individuals who constantly perceive daily stress.
4. Individuals who spend 30 minutes or more outdoors during the day (e.g., during commuting) without sunglasses.
5. Individuals who are able to give informed consent to participate in this study after receiving a detailed explanation of the protocol and understanding its contents.
Key exclusion criteria
1. Individuals who regularly consume Foods for Specified Health Uses, Foods with Function Claims, or health foods (including supplements) that may affect the study (including sleep improvement and stress reduction claims) and are unable to discontinue use from one month before the pre-examination and test food intake.
2. Individuals who take medications (e.g., antibiotics, laxatives, gastrointestinal drugs) that may affect the study and who cannot restrict their use during the study period.
3. Individuals who are receiving medical care or drug treatment for a disease that may affect the study.
4. Individuals diagnosed with severe anemia based on pre-examination blood test results.
5. Individuals with a habit of consuming foods/beverages containing cacao, cocoa, or cocoa butter (once a week or more).
6. Individuals who dislike chocolate.
7. Individuals with bruises or scars on the skin measurement area (inner side of the left forearm).
8. Individuals who are participating in, have participated in within the four weeks prior to the current trial, or are planning to participate in clinical trials of pharmaceuticals or health foods.
9. Individuals with extremely irregular lifestyles (such as night shifts, irregular shift work, or irregular sleep habits).
10. Individuals with excessive alcohol intake.
11. Individuals who are in the habit of smoking, or have been in the habit of smoking within the past six months.
12. Individuals who, at the time of consent acquisition, have plans involving significant changes in lifestyle or sleep habits (e.g., overseas business trips of 2 weeks or longer) during the study period.
13. Individuals who will develop hay fever symptoms during the study period, or who plan to take medication during the same period.
14. Individuals with previous and/or current medical history of serious diseases in the heart, liver, kidney, digestive organs, etc., (including perioperative period).
Target sample size
24
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
LOTTE 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
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 | 11 | 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
| 2025 | Year | 10 | Month | 29 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Exclusion criteria continued)
15. Individuals with allergies to medications and/or food (specifically eggs, wheat, cacao, milk, and soybeans).
16. Individuals who donated 200 mL of his blood or blood components within the last month.
17. Individuals who donated 400 mL of his blood within the last 3 months.
18. Individuals who have had a total of 1200 mL of his blood collected within the last 12 months, including in this study.
19. Individuals deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Management information
Registered date
| 2025 | Year | 11 | Month | 14 | Day |
Last modified on
| 2025 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067801
