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Intervention Study using food design system development for young adults with untreated first-degree hypertension or lower

Development of a rich food design system based on a healthy Japanese diet for young adults with untreated first-degree hypertension or lower -Randomized parallel group comparative study-

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1050240271
Enrollment
240
Registered
2025-02-17
Start date
2025-02-17
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

Grade 1 hypertension or normotensive young adult

Interventions

Evaluate and compare changes in blood pressure after consuming three different types of bento for four weeks

Sponsors

Kokubo Yoshihiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Eligibility criteria for provisional registration 1. Those aged 20 to 39 at the time of application 2. Those who have given written consent Eligibility criteria for complete registration 1. Those who are not receiving hypertension treatment and have a systolic blood pressure of less than 160 mmHg in the clinic blood pressure screening test performed after provisional registration 2. Those who can participate in the intervention diet and all tests for four consecutive weeks

Exclusion criteria

Exclusion criteria: Exclusion criteria for provisional registration 1. Those currently receiving treatment for hypertension, diabetes, or dyslipidemia 2. Those with a history of the following illnesses: cardiovascular disease, liver disease, pancreatic disease, chronic kidney disease, cancer, thyroid disease, or mental illness 3. Those who cannot consume certain foods for any reason, such as food allergies 4. Those currently 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, breastfeeding women, or women participating in the study who are planning to become pregnant 7. Those who have a drinking habit of drinking an average of 2 go (equivalent to 2 cups) of sake per day 8. Those who are already participating in other studies or plan to participate during the study period 9. Those who cannot secure 18 L 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 Exclusion criteria for complete registration 1. Those who bring in blood test results from the baseline survey or health check result sheet (within one year of application) will have their health check results checked, and those with HbA1c equal or more than 6.5%, fasting blood glucose equal or more than 126 mg/dL, casual blood glucose equal or more than 200 mg/dL, LDL cholesterol equal or more than 180 mg/dL, eGFR less than 60 mL/min/1.73 m2, or urinary protein equal or more than 2+ in a qualitative urine test will be considered. 2. Those scheduled to make a long-term business trip or travel for more than one week during the study participation period. 3. Those who are deemed by a doctor to be inappropriate to participate in this study.

Design outcomes

Primary

MeasureTime frame
Changes in mean systolic blood pressure between the second and third visit blood pressure measurements at baseline and after dietary intervention

Contacts

Public ContactYukako Iida

National Cerebral and Cardiovascular Center

ykokubo@ncvc.go.jp+81-661701070

Outcome results

None listed

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