Tokyo, Jan. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060346) titled 'Safety Evaluation of Excessive Intake of the Ceramide-Containing Food' on Jan. 20.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - IMEQRD Co. Ltd.

Condition: Condition - Healthy adults Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: Interventions/Control_1 - Participants will take 15 capsules of the study food daily with water or lukewarm water for four weeks.

Eligibility: Age-lower limit - 20 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 Size - 10

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 09 Day Anticipated trial start date - 2026 Year 02 Month 25 Day Last follow-up date - 2026 Year 04 Month 08 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068987

Disclaimer: Curated by HT Syndication.