Tokyo, June 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061961) titled 'A Safety Evaluation of Excessive Intake of the Study Food: A Randomized, Open-Label, Placebo-Controlled, Parallel-Group Study' on June 28.

Study Type: Interventional

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

Primary Sponsor: Institute - IMEQRD Co., Ltd.

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

Objective: Narrative objectives1 - The aim of this study is to assess the safety of the test food by having healthy men and women aged 20 to under 60 consume 600 mL/day ( three times the standard amount ) for four weeks. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Participants will consume 600 mL of the test food daily for four weeks. Interventions/Control_2 - Participants will consume 600 mL of the placebo food daily for four weeks.

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1. Aged 20 to under 60 2. Japanese men and women 3. BMI less than 30.0 kg/m^2 4. Able to enter electronic diary data via smartphone or PC 5. Able to refrigerate the study food 6. Provided written informed consent after receiving a full explanation and understanding the study Key exclusion criteria - 1. Currently receiving treatment for any illness with medication (including Kampo), or attending medical care (as-needed use permitted) 2. Under dietary or exercise therapy supervised by a physician 3. History or presence of serious liver, kidney, heart, respiratory, endocrine, or metabolic disorders 4. Used antibiotics within one month before consent or plans to use during the study 5. Scheduled for endoscopy, barium meal, H. pylori eradication, or tooth extraction during the study 6. History of gastrointestinal surgery (except appendectomy) 7. Unwilling or unable to consume the study food 8. Previously diagnosed with high blood glucose or elevated triglycerides, or with a family history of diabetes or prediabetes 9. Prone to constipation or diarrhea 10. Regular use of over-the-counter drugs, quasi-drugs, Foods for Specified Health Uses, health foods, or supplements (unless discontinued after consent) 11. History or presence of drug or food allergies, or risk of allergic reaction to the study food 12. Habitual excessive alcohol intake (>=40g pure alcohol/day) 13. Habitual heavy smoking (>=21 cigarettes/day) 14. Shift workers with night shifts 15. Plans to significantly change lifestyle (diet, sleep, exercise, etc.) during the study 16. Plans to travel abroad during the study 17. Unable to refrain from frequent snacking or consuming sugary drinks during the study 18. Pregnant, breastfeeding, or planning pregnancy during the study 19. Presence of metal implants due to surgery 20. Use of a pacemaker or other implantable medical device 21. Participation in another clinical study within one month prior to consent, currently participating, or planning to participate during the study 22. Deemed unsuitable for participation by the principal investigator Target Size - 48

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 19 Day Date of IRB - 2026 Year 05 Month 26 Day Anticipated trial start date - 2026 Year 06 Month 29 Day Last follow-up date - 2026 Year 09 Month 28 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068929

Disclaimer: Curated by HT Syndication.