Intervention study using food design system development

JRCT ID: jRCT1050240156

Registered date:09/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Elevated Blood Pressure
• Date of first enrollment: 09/10/2024
• Target sample size: 150
• Study type: Interventional
• Intervention(s): The participants will consume three types of bento for 12 weeks and compare changes in blood pressure.

Outcome(s)

• Primary Outcome: Changes in mean systolic blood pressure between the second and third examinations between the baseline and post-dietary intervention blood pressure measurements

Secondary Outcome

Diastolic blood pressure pulse rate at the time of examination
Limb systolic and diastolic blood pressure
Heartnote pulse rate
Systolic blood pressure diastolic blood pressure pulse rate at home blood pressure measurement
Coefficient of variation of systolic and diastolic blood pressure at the time of examination and at home blood pressure
Lifelong health support ten
Blood pressure category

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 40age old
• Gender: Both

Include criteria

(1)Recruitment criteria
1 Those aged 20 to 39 at the time of application
2 Those who can bring their most recent health check results within the last three years from the date of application
3 Those whose systolic blood pressure falls within the range of 125 to 145 mmHg in any of 1) to 2)
1) Most recent health check results
2) Results from an automatic blood pressure monitor at a hospital or public facility within one month prior to application
4 Those who can visit the National Cerebral and Cardiovascular Center
5 Those who have given written consent

Exclude criteria

Recruitment Exclusion Criteria
1Those whose most recent health check results show HbA1c 6.1% or more, LDL cholesterol 160mg/dL or more, and serum creatinine 1.2mg/dL or more for men and 1.0mg/dL or more for women.
2 Those with a current or past medical history of the following: cardiovascular disease, liver disease, pancreatic disease, hypertension, diabetes, dyslipidemia, chronic kidney disease, cancer, thyroid disease, or psychiatric disease.
3 Those who cannot consume certain foods due to food allergies or other reasons.
4 Those who are undergoing dietary management under the guidance of a doctor or registered dietitian.
5 Those who have had abdominal surgery or a fracture within 6 months of the application date.
6 Pregnant women, locating women, or women who are participating in the study and planning to become pregnant.
7 Those who have a daily alcohol intake habit of 2 cups of sake or more per day.
8 Those who are already participating in other studies or plan to participate during the study period.
9 Those who cannot secure 18L of freezer space to store the intervention food.
10 Those who are deemed inappropriate for participation in this study by a doctor for other reasons.

Related Information

• Primary Sponsor: Kokubo Yoshihiro
• Source(s) of Monetary Support: National Agriculture and Food Research Organization