Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060140) titled 'A verification study of the test food intake on immune function' on April 1.

Study Type: Interventional

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

Primary Sponsor: Institute - Oryza Oil & Fat Chemical Co. Ltd.

Condition: Condition - To verify the effects of consumption of the test food on immune function in healthy Japanese subjects. Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To verify the effects of consumption of the test food on immune function in healthy Japanese subjects. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Duration: 8 weeks Test food: Tablet containing plant extract Administration: Take 1 capsule per day. Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the day. Interventions/Control_2 - Duration: 8 weeks Test food: Placebo tablet Administration: Take 1 capsule per day *Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the day.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Japanese 2. Men or women 3. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who are judged as eligible to participate in study by the physician Key exclusion criteria - 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects who currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use 5. Subjects who currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, lactation, or planning to become pregnant 8. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 9. Subjects who are judged as ineligible to participate in the study by the physician 10. Subjects who have been vaccinated against influenza within three months 11. Subjects who suffer from COVID-19 Target Size - 22

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 11 Month 01 Day Date of IRB - 2025 Year 11 Month 13 Day Anticipated trial start date - 2025 Year 12 Month 01 Day Last follow-up date - 2026 Year 02 Month 15 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068779

Disclaimer: Curated by HT Syndication.