Tokyo, Nov. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059632) titled 'A study to verify the safety of consumption of the test food: a randomized, placebo-controlled, double-blind, parallel-group comparison study' on Nov. 4.

Study Type: Interventional

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

Primary Sponsor: Institute - Toyama Prefectural Institute for Pharmaceutical Research

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

Objective: Narrative objectives1 - To verify the safety of consumption of the test food in healthy Japanese. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Duration: Four weeks Test product: Capsule containing high-dose isoliquiritigenin (ILG) licorice extract powder Administration: Consume one capsule once per day preferably at the same time each day, with water without chewing.

*If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and should not be carried over to the following day. Interventions/Control_2 - Duration: Four weeks Test product: Placebo capsule Administration: Consume one capsule once per day preferably at the same time each day, with water without chewing.

*If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and should not be carried over to the following day.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Japanese

2. Men or women

3. Adults

4. Healthy individuals Key exclusion criteria - 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction

2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"

5. Individuals who are taking or using medicines (including herbal medicines) or supplements

6. Individuals who are allergic to medicines or foods related to the test product

7. Individuals who are pregnant, lactating, or planning to become pregnant during this study

8. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study

9. Individuals who are judged as ineligible to participate in this study by the physician Target Size - 20

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 10 Month 22 Day Date of IRB - 2025 Year 10 Month 22 Day Anticipated trial start date - 2025 Year 11 Month 04 Day Last follow-up date - 2026 Year 01 Month 27 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068207

Disclaimer: Curated by HT Syndication.