Tokyo, Oct. 24 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059511) titled 'A study to evaluate the safety of excessive consumption of the test food' on Oct. 23.

Study Type: Interventional

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

Primary Sponsor: Institute - Pharma Foods International Co., Ltd.

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

Objective: Narrative objectives1 - To evaluate the safety of consuming the test food at five times the usual daily intake. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Intervention period: Four weeks Follow-up period: Two weeks Test product: Food containing plant-derived ingredients Interventions/Control_2 - Intervention period: Four weeks Follow-up period: Two weeks Test product: Placebo food

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 pharmaceuticals, investigational products, or related foods

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 - 30

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 10 Month 08 Day Date of IRB - 2025 Year 10 Month 08 Day Anticipated trial start date - 2025 Year 10 Month 23 Day Last follow-up date - 2026 Year 01 Month 25 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068071

Disclaimer: Curated by HT Syndication.