Tokyo, Sept. 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059139) titled 'Lifestyle Intervention Study for Healthy Blood Pressure Through Gut Environment Modulation' on Sept. 19.

Study Type: Interventional

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

Primary Sponsor: Institute - Metagen, Inc.

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

Objective: Narrative objectives1 - To evaluate the efficacy of dietary ingredient intake in improving hypertension through modulation of the gut environment Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Consumption of the test food (1 carton per day)

Eligibility: Age-lower limit - 40 years-old

Gender - Male Key inclusion criteria - (1) Male subjects aged 40 over but under 8 at the time conset was obtained. (2) Subjects with "high normal" or "high" blood pressure readings taken in a clinic/home blood pressure. (3) Subjects who do not attending regular hospital visits for the purpose of treatment related to high blood pressure. (4) Subjects who can show their understanding of the study procedure and agreement with participating in the study by informed consent prior to the study. Key exclusion criteria - (1) Subjects who are unable to discontinue consumption of products equivalent to "vinegar drink" from consent acquisition to the conclusion of the trial (use of vinegar as a condiment is permissible). (2) Subjects who are participating in a clinical study of another drug or health food, or within 4 weeks of the completion of the study, or who is scheduled to participate in another clinical study after consent to participate in this study. (3) Subjects with extremely irregular lifestyles (late-night work, shift work, etc.). (4) Subjects with extremely irregular eating habits. (5) Heavy alcohol drinkers. (6) Subjects whose roommates plan to participate in the study. (7) Subjects who are expected to undergo a major change in their family, work, or other living environment (e.g., relocation, transfer, etc.) during the study. (8) Subjects who have taken drugs (antibiotics, antiflatulent, laxatives, etc.) that would affect the study, one month prior to the preliminary test, or during the study. (9) Subjects undergoing medication treatment for ongoing care. (10) Subjects who have undergone surgery that may affect the study (colonoscopy, removal of gallstones or gallbladder, gastric bypass surgery, etc.) within 6 months prior to obtaining consent. (11) Subjects with a history of appendectomy. (12) Subjects currently receiving treatment with antihypertensive agents, or those who have previously received the treatment (13) Subjects with a history of serious diseases of the heart, liver, kidneys, digestive organs, etc. (14) Subjects allergic to medicines and foods. (15) Subjects who are judged by the principal investigator or sub-investigator to be inappropriate to participate in this study. Target Size - 12

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 08 Month 15 Day Date of IRB - 2025 Year 08 Month 15 Day Anticipated trial start date - 2025 Year 09 Month 30 Day Last follow-up date - 2025 Year 12 Month 25 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067647

Disclaimer: Curated by HT Syndication.