Tokyo, July 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058518) titled 'A study to assess the impact of a test food on blood biomarkers, sensory indicators, and its absorption in healthy adult males' on July 22.

Study Type: Interventional

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

Primary Sponsor: Institute - IMEQRD Co., Ltd.

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

Objective: Narrative objectives1 - To explore the effects of a test food on blood biomarkers and sensory indicators in healthy adult males. In addition, measuring blood concentrations after intake of a test food. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intake the test food once a day for four weeks.

Eligibility: Age-lower limit - 20 years-old = Gender - Male Key inclusion criteria - 1)Those who provided written informed consent to participate in the study. 2)Healthy Japanese males aged 20-69 years at the time of providing informed consent to participate in the study. 3)Those who are able to visit the clinic on the designated examination dates and undergo the required tests. Key exclusion criteria - 1)Individuals whose clinical laboratory values deviate significantly from the reference range and who are deemed ineligible for the study by the principal investigator. 2)Individuals with a serious medical history involving major organs or systems, or those currently undergoing treatment, who are deemed ineligible for the study by the principal investigator. 3)Individuals taking antihypertensive medication. 4)Individuals with implanted medical electrical devices such as pacemakers. 5)Individuals with a current or past history of drug or food allergies. 6)Individuals otherwise deemed unsuitable as study subjects by the principal investigator or study coordinator. Target Size - 45

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 07 Month 15 Day Date of IRB - 2025 Year 07 Month 15 Day Anticipated trial start date - 2025 Year 07 Month 22 Day Last follow-up date - 2025 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066913

Disclaimer: Curated by HT Syndication.