Clinical Trial: Evaluation of the Effects of Long-Term Consumption of the Test Food on Blood Pressure and Lipid Metabolism : placebo-controlled, double-blind, randomized parallel comparative study (Japan)

Tokyo, July 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062088) titled 'Evaluation of the Effects of Long-Term Consumption of the Test Food on Blood Pressure and Lipid Metabolism' on July 6.

Study Type: Interventional

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

Primary Sponsor: Institute - Miura Clinic, Medical Corporation Kanonkai

Condition: Condition - Adults with elevated LDL cholesterol levels and slightly high blood pressure. Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the effects of long-term consumption of the test food on blood pressure and lipid metabolism. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intake the test food for 12 weeks Interventions/Control_2 - Intake the placebo food for 12 weeks

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - (1) Male and female subjects aged 35 to 59 years. (2) Subjects with a systolic blood pressure of 120 mmHg or higher, or a diastolic blood pressure of 80 mmHg or higher. (3) Subjects with an LDL cholesterol level of 120 mg/dL or higher. (4) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing Key exclusion criteria - (1) Subjects with a history of serious diseases such as mental disorders, diabetes, liver diseases, renal diseases, gastrointestinal diseases, cardiac diseases, respiratory diseases, peripheral vascular diseases, or other severe diseases. (2) Subjects who have undergone gastrointestinal surgery. (3) Subjects with abnormal liver or renal function test values. (4) Subjects with diseases currently under treatment. (5) Subjects with allergies to food or drugs. (6) Subjects with symptoms of anemia. (7) Female subjects who wish to become pregnant during the study, or who are pregnant (including those who may be pregnant) or lactating. (8) Subjects who engage in intense sports or who are on a diet. (9) Subjects with extremely irregular eating habits. (10) Subjects who cannot discontinue the intake of health foods (including foods for specified health use and foods with functional claims) or quasi-drugs during the study period. (11) Subjects who are continuously treated with pharmaceuticals (including OTC and prescription drugs). (12) Subjects who consume more than 40 g of pure alcohol per day on average. (13) Subjects who smoke 21 or more cigarettes per day on average. (14) Subjects who are participating in or will participate in other clinical studies at the start of this study. (15) Subjects who are judged by the principal investigator or subinvestigator to be inappropriate for the study. Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 19 Day Date of IRB - 2026 Year 06 Month 25 Day Anticipated trial start date - 2026 Year 07 Month 07 Day Last follow-up date - 2026 Year 11 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071038

Disclaimer: Curated by HT Syndication.