Tokyo, Nov. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059713) titled 'Human safety test of Macaranga tanarius fruit extract' on Nov. 10.

Study Type: Interventional

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

Primary Sponsor: Institute - Southen Knights' Laboratory Co., Ltd.

Condition: Condition - healthy adult Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Macaranga tanarius (scientific name: Macaranga tanarius) grows wild south of the Ryukyu Islands. The prenylflavonoids contained in Macaranga tanarius exhibit strong antibacterial and antioxidant properties, and have been reported to have antibacterial, anti-inflammatory, antioxidant, anti-cancer properties, promote glucose uptake in skeletal muscle cells, and promote tooth germ formation. Furthermore, Macaranga tanarius fruit ethanol extract has been shown to suppress weight gain and blood sugar levels in obese and diabetic model mice. Safety tests showed no safety issues when administered to rats and mice at 2g/kg of Macaranga tanarius fruit extract (test product). Thus, if Macaranga tanarius fruit extract is commercialized, it is expected to promote health through its anti-inflammatory, blood sugar-lowering, and anti-obesity properties. Therefore, in this study, we first conducted human safety tests. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - The test product will be a No. 2 hard capsule (made of hydroxypropyl methylcellulose) containing 100 mg of Macaranga tanarius fruit extract. The administration period will generally be four weeks, and the drug will be taken once daily in the morning. Interventions/Control_2 - The placebo will be a No. 2 hard capsule containing dextrin. The administration period will generally be four weeks, and the drug will be taken once daily in the morning.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - Basically, healthy men and women aged 20 to 65 Key exclusion criteria - Participants who meet any of the following criteria will be excluded. 1) Participants currently receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction. 2) Participants with a pacemaker or implantable cardioverter-defibrillator. 3) Participants currently receiving treatment for the following chronic diseases: arrhythmia, liver damage, chronic kidney disease, cerebrovascular disease, rheumatic disease, diabetes, dyslipidemia, hypertension, cardiovascular disease, and other chronic diseases. 4) Participants currently taking foods for specified health uses or foods with functional claims. 5) Participants currently taking or using medicines (including herbal medicines) or supplements. 6) Participants with allergies (to medicines or foods related to the test food). 7) Participants currently pregnant, breastfeeding, or intending to become pregnant during the study period. 8) Participants who have participated in other clinical trials within the 28 days prior to the consent acquisition date, or who plan to participate in such trials during the study period. 9) Participants deemed inappropriate for this study by the investigator. Target Size - 30

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2025 Year 06 Month 10 Day Date of IRB - 2025 Year 08 Month 05 Day Anticipated trial start date - 2025 Year 09 Month 08 Day Last follow-up date - 2025 Year 11 Month 05 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067132

Disclaimer: Curated by HT Syndication.