Tokyo, Dec. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000055038) titled 'A verification study to evaluate the safety of long-term consumption of the test food' on Dec. 22.

Study Type: Interventional

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

Primary Sponsor: Institute - ORTHOMEDICO Inc.

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

Objective: Narrative objectives1 - To verify the safety of consumption of the test food for 12 weeks in healthy Japanese. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Duration: 12 weeks Test food: Lactic acid bacteria powder Interventions/Control_2 - Duration: 12 weeks Test food: Hydrolysate of rice protein

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1. Japanese

2. Men or women

3. Healthy individuals

4. Individuals aged 20 or more and less than 70 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 medications (including herbal medicines) and supplements

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

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 planning to undergo gastrointestinal surgery or colonoscopy

10. Individuals who are undergoing medical treatment for immunodeficiency disorders

11. Individuals who are suffering from valvular heart disease

12. Individuals who are judged as ineligible to participate in this study by the physician Target Size - 60

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2024 Year 07 Month 10 Day Date of IRB - 2024 Year 07 Month 10 Day Anticipated trial start date - 2024 Year 07 Month 22 Day Last follow-up date - 2024 Year 12 Month 22 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062875

Disclaimer: Curated by HT Syndication.