Tokyo, June 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061879) titled 'An Exploratory Study Evaluating the Effects of a Test Food on Aging-Related Indicators - Single-arm, open-label study -' on June 11.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Medical Corporation Heishinkai ToCROM Clinic

Condition: Condition - Healthy volunteers Classification by malignancy - Others Genomic information - YES

Objective: Narrative objectives1 - To evaluate the effects of continuous intake of the test food on Aging-Related Indicator in adult men and women. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Intake of test food for 24 weeks (once a day, 3 capsules)

Eligibility: Age-lower limit - 40 years-old = Gender - Male and Female Key inclusion criteria - 1) Men and women aged 40-55 years 2) BMI >=25.0 and =21 cigarettes/day. 8) Subjects consuming excessive alcohol (>=21 g alcohol/day). 9) Subjects consuming excessive caffeinated beverages (>=7 cups of coffee/day). 10) Subjects with self-reported food allergies. 11) Subjects who are pregnant, breastfeeding, or planning pregnancy during the study period. 12) Subjects who participated in another clinical study within 1 month before informed consent or plan to participate in another study during the study period. 13) Subjects who donated 200 mL or 400 mL whole blood, received a blood transfusion within 3 months before testing, or donated blood components within 2 weeks before testing. 14) Subjects deemed unsuitable based on screening assessments. 15) Subjects currently participating in, or intending to participate in, another study involving foods, medications, cosmetics, quasi-drugs, or pharmaceuticals. 16) Subjects otherwise judged unsuitable by the principal investigator or sub-investigators. Target Size - 48

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 27 Day Date of IRB - 2026 Year 05 Month 21 Day Anticipated trial start date - 2026 Year 06 Month 12 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070801

Disclaimer: Curated by HT Syndication.