Tokyo, July 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058465) titled 'A study to evaluate the safety of long-term consumption of the test food' on July 14.

Study Type: Interventional

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

Primary Sponsor: Institute - Cerebro Pharma Inc.

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

Objective: Narrative objectives1 - To verify the safety of long-term consumption of the test food. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Duration: 12 weeks Test product: Food containing Zizyphi spinosi semen seed powder Administration: Take two capsules per day with water after the first meal of the day.

*If you forget to take the test food, take it as soon as you remember. The daily dose should be taken within the day and not carried over to the next 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 07 Month 09 Day Date of IRB - 2025 Year 07 Month 09 Day Anticipated trial start date - 2025 Year 07 Month 14 Day Last follow-up date - 2025 Year 12 Month 08 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066845

Disclaimer: Curated by HT Syndication.