Study of the superiority of Complete Nutrition Meals in hypertensive patients.
- Conditions
- Essential Hypertension
- Registration Number
- JPRN-UMIN000049667
- Lead Sponsor
- EP Mediate Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 400
Not provided
(1) Subjects who cannot continuously ingest research foods due to business trips etc. during the intake period. (2) Subjects with concomitant diabetes mellitus. (3) Subjects with severe hepatic impairment (4) subjects with renal impairment. (5) Subjects who self-reported a weight change of 5% or more within 3 months before the pre-examination. (6) Subjects with a history of myocardial infarction or stroke within the past year. (7) Subjects who are planning to change, add new or discontinue the treatment method for hypertension between the pre-examination and the intake start examination. (8) Subjects with food allergies. (9) Subjects with an average daily alcohol intake of more than 60 g. (10) Subjects with a smoking habit of more than 21 cigarettes per day. (11) Subjects who are judged by the principal investigator to be at risk of being hospitalized or having dietary restrictions etc. that may affect the continuation of the study or the intake of the research foods. (12) Subjects with diseases that may turn into serious adverse events during the study period, such as cancer. (13) Subjects who cannot properly store and ingest research foods due to reasons such as the inability to install a freezer to distribute and the lack of a microwave oven. (14) Subjects who cannot record diary or answer questionnaires on the Web. (15) Subjects with implantable medical devices such as cardiac pacemakers or life-sustaining medical devices such as biometric monitors. (16) Subjects who are planning to become pregnant or breastfeed during the study period. (17) Subjects who are participating in other clinical studies (including clinical trials) at the start of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinic blood pressure Evaluate before ingestion, 6 weeks, 12 weeks, 18 weeks and 24 weeks after ingestion.
- Secondary Outcome Measures
Name Time Method Therapeutic intensity score Drug change score Number of drug types Home blood pressure (morning, night) Physical measurement (body weight, BMI, abdominal circumference) Body-fat percentage QOL examination Physical activity Meal record (BDHQ) Fasting clinical examination Evaluate before ingestion, 6 weeks, 12 weeks, 18 weeks and 24 weeks after ingestion.