Tokyo, Aug. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062270) titled 'Verification of the effects of Peucedanum japonicum root extract on abdominal fat -Randomized, placebo-controlled, double-blind, parallel group study-' on Aug. 31.

Study Type: Interventional

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

Primary Sponsor: Institute - Maruzen Pharmaceuticals Co., Ltd.

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

Objective: Narrative objectives1 - To verify for effects of abdominal fat reduction when supplementing with Peucedanum japonicum root extract for 12 weeks in healthy Japanese male and female adults with BMI of 23.0 or more and less than 30.0 kg/m2 who tend to consume foods high in fat Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Intake of active food for 12 weeks Interventions/Control_2 - Intake of placebo food for 12 weeks

Eligibility: Age-lower limit - 40 years-old = Gender - Male and Female Key inclusion criteria - 1) Healthy Japanese males and females aged of 40-60 years 2) Participants whose BMI >=23.0 kg/m2 and <30.0 kg/m2 3) Participants who tend to consume foods high in fat 4) Participants who can visit on schedule days 5) Participants who recognize the object and contents of the study and submit the written informed consent Key exclusion criteria - 1) Participants who are under treatment or have a history of severe illness in the heart, liver, kidney, digestive organs or other organs 2) Participants who have been diagnosed or taking medication with dyslipidemia, high blood pressure, or diabetes 3) Participants who received medication treatment or surgery due to serious illness or injury within 1 month from the start of this study 4) Participants who regularly use health foods and supplements affecting the study 5) Participants who may have difficulties during CT scanning (e.g. claustrophobia, metal in the vicinity of imaging, implanted medical devices in the body) 6) Possible pregnancy, pregnancy and lactation 7) Heavy drinker (over 40g alcohol/day) 8) Smokers 9) Participants who feel bad mood by blood collect 10) Participants who donated 200 mL or more of blood within 1 month prior to the start of the study or participants who plan to do so during the study period 11) Participants who have been diagnosed with chronic constipation 12) Late-night Shift worker 13) Participants who plan business trip or trip on average more than 10 days per month (excluding Obon vacation and New Year's holidays) 14) Participants who have allergy related to the test foods 15) Participants already participating in other clinical trials 16) Participants who are ineligible due to physician's judgment Target Size - 90

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 07 Day Date of IRB - 2026 Year 07 Month 13 Day Anticipated trial start date - 2026 Year 08 Month 31 Day Last follow-up date - 2026 Year 12 Month 05 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071257

Disclaimer: Curated by HT Syndication.