UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060346 |
|---|---|
| Receipt number | R000068987 |
| Scientific Title | Safety Evaluation of Excessive Intake of the Ceramide-Containing Food - Single-Arm, Open-Label Trial - |
| Date of disclosure of the study information | 2026/01/20 |
| Last modified on | 2026/01/09 11:23:42 |
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Basic information
Public title
Safety Evaluation of Excessive Intake of the Ceramide-Containing Food
Acronym
Safety Evaluation of Excessive Intake of the Ceramide-Containing Food
Scientific Title
Safety Evaluation of Excessive Intake of the Ceramide-Containing Food
- Single-Arm, Open-Label Trial -
Scientific Title:Acronym
Safety Evaluation of Excessive Intake of the Ceramide-Containing Food
- Single-Arm, Open-Label Trial -
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety of the study food by having men and women aged 20 to under 65 consume five times the recommended daily amount for four consecutive weeks.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Physical examination (weight, BMI)
-Physiological assessments (blood pressure, pulse)
-Blood tests (hematology, blood biochemistry)
-Urinalysis
-Incidence of adverse events and side effects
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants will take 15 capsules of the study food daily with water or lukewarm water for four 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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Aged 20 to under 65
2. Japanese men and women
3. BMI less than 30.0 kg/m^2
4. Able to enter electronic diaries via smartphone or PC
5. Provided written informed consent after receiving a full explanation of the study and voluntarily agreeing to participate
Key exclusion criteria
1. Currently receiving outpatient treatment or medication (including Kampo) for any illness
2. Under physician-supervised dietary or exercise therapy
3. Current or past history of serious disease
4. Currently taking over-the-counter drugs, quasi-drugs, Foods for Specified Health Uses, Foods with Functional Claims, health foods, or supplements (except those who can discontinue use after consent and during the study)
5. Current or past drug or food allergies
6. Excessive alcohol consumption (>=40g pure alcohol/day)
7. Heavy smoking (>=21 cigarettes/day)
8. Shift workers with night shifts
9. Planning major lifestyle changes (diet, sleep, exercise, etc.) during the study
10. Planning overseas travel during the study period
11. Pregnant, breastfeeding, or planning pregnancy during the study
12. Participated in another clinical study within one month prior to consent, currently participating, or planning to participate during the study
13. Deemed unsuitable for participation by the principal investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Katsuyuki |
| Middle name | |
| Last name | Ishihara |
Organization
Calbee, Inc.
Division name
Research Department Research & Development Division
Zip code
321-3231
Address
23-6 Kiyoharakougyoudanchi, Utsunomiya, Tochigi, Japan
TEL
080-5952-8671
k_ishihara@calbee.co.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
Calbee, Inc.
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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.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
| 2026 | Year | 01 | Month | 20 | 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 | 12 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 08 | 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 | 01 | Month | 14 | Day |
Last modified on
| 2026 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068987
