Tokyo, Jan. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060255) titled 'Safety Evaluation of Excessive Intake of Maizinol (UP165) in Healthy Adults' on Jan. 5.

Study Type: Interventional

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

Primary Sponsor: Institute - Unigen Inc.

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

Objective: Narrative objectives1 - To evaluate the safety of Maizinol (UP165) following 4 weeks of excessive intake in healthy adults, focusing on adverse events and changes in clinical laboratory parameters. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Maizinol (UP165), 2500 mg/day, 20 capsules/day for 4 weeks Interventions/Control_2 - Placebo (Dextrin), 20 capsules/day for 4 weeks

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - 1. Japanese

2. Men or women

3. Individuals aged between 18 and 75

4. Healthy individuals

5. Individuals who are willing and able to provide informed consent and comply with all study procedures

6. Individuals who maintain a stable lifestyle, including regular meals, exercise, and sleep schedules

7. Individuals who are willing to refrain from taking any new supplements, functional foods, or medicines that may affect sleep or mood during the study period.

8. Individuals who are not allergic to corn or corn products related to the test product

9. Individuals who are able to understand and communicate in the language used in the informed consent and research materials

10. Individuals who are not currently or recently participating in other clinical trials 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, particularly those who are allergic to corn or corn 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 shift workers

10. 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 12 Month 10 Day Date of IRB - 2025 Year 12 Month 10 Day Anticipated trial start date - 2026 Year 01 Month 05 Day Last follow-up date - 2026 Year 04 Month 07 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068920

Disclaimer: Curated by HT Syndication.