Tokyo, Jan. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060452) titled 'Study on the Effects of Test Food Intake on Improving Cardiovascular Function - Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Trial -' on Jan. 25.

Study Type: Interventional

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

Primary Sponsor: Institute - TES Holdings Co., Ltd.

Condition: Condition - No Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to evaluate the effects on cardiovascular function-related indicators and the safety of continuous consumption of the test food. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Oral intake of the test food (1 capsule in a day; 12 weeks). Interventions/Control_2 - Oral intake of the placebo food (1 capsule in a day; 12 weeks).

Eligibility: Age-lower limit - 40 years-old

Gender - Male and Female Key inclusion criteria - 1) Men and women aged 40 years or older but under 65 years at the time of obtaining consent to participate in the trial. 2) Healthy individuals without chronic physical diseases, including skin diseases. 3) Individuals with LDL cholesterol in the borderline range (120 mg/dL to 139 mg/dL) or mildly elevated range (140 mg/dL to 159 mg/dL). 4) Individuals with slightly elevated blood pressure. 5) Individuals who have received sufficient explanation regarding the purpose and content of this trial, possess the capacity to consent, voluntarily volunteer to participate after fully understanding, and can provide written consent to participate in this trial. 6) Individuals who can attend the designated examination date and undergo the examination. 7) Individuals deemed suitable for participation in this trial by the principal investigator. Key exclusion criteria - Individuals 1) currently suffering from any disease and undergoing drug treatment. 2) with a current medical history of mental disorders, sleep disorders, hypertension, diabetes, dyslipidemia, or a past or current history of serious diseases. 3) with a history of serious past or current medical conditions involving the liver, kidneys, heart, lungs, blood, digestive organs, etc. 4) who have habitually taken or applied medications for disease treatment within the past month (excluding occasional use for conditions such as headaches or menstrual pain). 5) whose BMI is over 30 kg/m2. 6) who may experience allergic reactions to components contained in the test food, as well as individuals who may experience severe allergic reactions to other foods or pharmaceuticals. 7) with dietary habits that may affect test results. 8) who currently have, or have had within the past three months, a habit of continuously consuming foods for specified health uses, foods with functional claims, or health foods. 9) whose average weekly pure alcohol consumption exceeds 40 g/day for men and 20 g/day for women. 10) who have a smoking habit. 11) working rotating shifts or night shifts. 12) whose lifestyle may undergo significant changes during the examination period, such as extended business trips or travel. 13) who have donated blood exceeding 200 mL within the past month or 400 mL within the past 3 months. 14) who are pregnant, breastfeeding, or may become pregnant during the examination period 15) currently participating in other human clinical trials, or individuals who have participated in other human clinical trials within the past 3 months. 16) Other individuals deemed ineligible for this trial by the principal investigator. Target Size - 80

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 23 Day Date of IRB - 2025 Year 12 Month 25 Day Anticipated trial start date - 2026 Year 02 Month 21 Day Last follow-up date - 2026 Year 05 Month 22 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068922

Disclaimer: Curated by HT Syndication.