Tokyo, Dec. 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060175) titled 'Evaluation of the safety of excessive intake of a test product' on Dec. 23.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - KAGOME CO., LTD.

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

Objective: Narrative objectives1 - To evaluate the safety of excessive intake at five times the recommended daily intake of a test product for 4 weeks. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Ingestion of active food for 4 weeks Interventions/Control_2 - Ingestion of placebo food for 4 weeks

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1. Healthy Japanese men and women aged 20 to under 65 at the time of obtaining consent to participate in the trial 2. Individuals able to visit the trial hospital on the scheduled visit date 3. Individuals who fully understand the purpose and content of this trial and consented in writing prior to trial starts Key exclusion criteria - 1. Individuals with dysphagia 2. Individuals who have previously experienced feeling sick or worsening physical condition due to blood draws 3. Individuals whose average weekly alcohol consumption, converted to pure alcohol, exceeds 40 g/day 4. Smokers 5. Individuals who have irregular daily routines or eating habits 6. Individuals who are undergoing medical treatment due to illness or injury, or who are scheduled to undergo surgery during the trial period (excluding those prescribed medication for temporary symptoms such as colds or hay fever) 7. Individuals with a history or current presence of serious diseases of heart, liver, or kidney disease (including cases where it is a complication of another disease) 8. Individuals with a history or current presence of serious diseases such as cancer or tuberculosis 9. Individuals who are positive or suspected to be positive in infectious disease tests 10. Individuals at risk of showing allergic symptoms upon food 11. Individuals regularly consuming medications, quasi-drugs 12. Individuals regularly consuming specific health foods, functional foods, nutritional supplements (e.g. capsule supplements) (excluding those who can suspend consumption at the time of informed consent) 13. Individuals who donated or drawn 200 mL or more blood within one month prior to the screening test or plan to donate blood during the trial period 14. Individuals working rotating shifts, including night shifts, or night shift workers 15. Individuals participating in another clinical trial within the past one month 16. Women who are pregnant, breastfeeding, or planning to become pregnant during the trial period 17. Any other individuals deemed ineligible for this trial by the principal investigator Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 22 Day Date of IRB - 2025 Year 12 Month 22 Day Anticipated trial start date - 2026 Year 03 Month 02 Day Last follow-up date - 2026 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068818

Disclaimer: Curated by HT Syndication.