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Intervention study using food design system development

Development of a rich food design system based on a healthy Japanese diet -Randomized parallel group comparative study-

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1050240156
Enrollment
150
Registered
2024-10-09
Start date
2024-10-22
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elevated Blood Pressure young adult

Interventions

The participants will consume three types of bento for 12 weeks and compare changes in blood pressure.

Sponsors

Kokubo Yoshihiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Changes in mean systolic blood pressure between the second and third examinations between the baseline and post-dietary intervention blood pressure measurements

Secondary

MeasureTime frame
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

Contacts

Public ContactYuka Kato

National Cerebral and Cardiovascular Center

kenken@ncvc.go.jp+81-661701070

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026