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Safety Evaluation of Excessive Intake of the Ceramide-Containing Food

Safety Evaluation of Excessive Intake of the Ceramide-Containing Food - Single-Arm, Open-Label Trial - - Safety Evaluation of Excessive Intake of the Ceramide-Containing Food - Single-Arm, Open-Label Trial -

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000060346
Enrollment
10
Registered
2026-01-20
Start date
2026-02-25
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adults

Interventions

Participants will take 15 capsules of the study food daily with water or lukewarm water for four weeks.

Sponsors

IMEQRD Co. Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
-Physical examination (weight, BMI) -Physiological assessments (blood pressure, pulse) -Blood tests (hematology, blood biochemistry) -Urinalysis -Incidence of adverse events and side effects

Countries

Japan

Contacts

Public ContactYoshitada Hira

IMEQRD Co., Ltd. Planning and Sales Department

clinical-trial@imeqrd.co.jp03-6704-5968

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026