Effects of Beetroot Juice Intake on Vascular Function in Hypertensive Patients on Antihypertensive Treatment

UMIN ID: UMIN000056207

Registered date:20/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hypertension
• Date of first enrollment: 2024/11/15
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

After obtaining informed consent and conducting pre-screening, participants will be randomized to consume the assigned juice (either beetroot juice or placebo juice) for 4 weeks, followed by a vascular function test. After a 4-week washout period, a vascular function test will be performed again. Subsequently, participants will consume the alternate juice (beetroot juice if they initially consumed placebo juice, or placebo juice if they initially consumed beetroot juice) for 4 weeks, followed by another vascular function test. Consume one bottle (70ml) of beetroot juice once daily with breakfast for 4 weeks. Consume one bottle (70ml) of placebo juice once daily with breakfast for 4 weeks.
After obtaining informed consent and conducting pre-screening, participants will be randomized to consume the assigned juice (either beetroot juice or placebo juice) for 4 weeks, followed by a vascular function test. After a 4-week washout period, a vascular function test will be performed again. Subsequently, participants will consume the alternate juice (beetroot juice if they initially consumed placebo juice, or placebo juice if they initially consumed beetroot juice) for 4 weeks, followed by another vascular function test. Consume one bottle (70ml) of beetroot juice once daily with breakfast for 4 weeks. Consume one bottle (70ml) of placebo juice once daily with breakfast for 4 weeks.

Outcome(s)

• Primary Outcome: The average change in FMD before and after 4 weeks of consuming beetroot juice or placebo juice.
• Secondary Outcome: The average percentage change in FMD before and after 4 weeks of consuming beetroot juice or placebo juice. The average FMD value after 4 weeks of consuming beetroot juice or placebo juice. The trend in the average FMD value before and after 4 weeks of consuming beetroot juice or placebo juice. The average change in nitroglycerin-induced vasodilation (NID) before and after 4 weeks of consuming beetroot juice or placebo juice. The average percentage change in NID before and after 4 weeks of consuming beetroot juice or placebo juice. The average NID value after 4 weeks of consuming beetroot juice or placebo juice. The trend in the average NID value before and after 4 weeks of consuming beetroot juice or placebo juice. The average change in brachial-ankle pulse wave velocity (baPWV) before and after 4 weeks of consuming beetroot juice or placebo juice. The average percentage change in baPWV before and after 4 weeks of consuming beetroot juice or placebo juice. The average baPWV value after 4 weeks of consuming beetroot juice or placebo juice. The comparison of the average baPWV value before and after 4 weeks of consuming beetroot juice or placebo juice with the average baPWV value at 4 weeks. The average change in office systolic and diastolic blood pressure before and after 4 weeks of consuming beetroot juice or placebo juice. The average office systolic and diastolic blood pressure values after 4 weeks of consuming beetroot juice or placebo juice. The trend in the average office systolic and diastolic blood pressure values before and after 4 weeks of consuming beetroot juice or placebo juice.

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. Patients currently receiving nitrate medications. 2. Patients with severe heart valve disease. 3. Patients with NYHA Class III or higher heart failure. 4. Patients with severe arrhythmias or who have had an implantable cardioverter-defibrillator (ICD) inserted. 5. Patients with end-stage renal failure (undergoing dialysis). 6. Patients with malignant diseases. 7. Patients currently using adrenal corticosteroids or immunosuppressive drugs. 8. Patients with cirrhosis. 9. Patients with peripheral arterial disease or unhealed wounds in the measured upper limbs, patients with venous stasis such as varicose veins, or patients with a shunt. 10. Patients with severe hypotension or cardiogenic shock. 11. Patients with closed-angle glaucoma. 12. Patients with a history of head trauma or intracerebral hemorrhage. 13. Patients with severe anemia. 14. Patients with a history of hypersensitivity to nitrate or nitrite ester-based medications. 15. Patients currently receiving phosphodiesterase-5 inhibitors (e.g., sildenafil citrate, vardenafil hydrochloride, tadalafil) or guanylate cyclase stimulators (e.g., riociguat, vericiguat). 16. Patients with diabetes mellitus. 17. Patients with an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2. 18. Patients with latex allergy. 19. Pregnant women, women who may be pregnant, women breastfeeding, or women planning to become pregnant. 20. Research subjects who are in a student-teacher relationship with the researcher, such as students taking a class from the research leader or research team members, putting them in a vulnerable position. 21. Any other individuals deemed inappropriate by the research leader or research team members.

Related Information

• Primary Sponsor: Hiroshima University
• Source(s) of Monetary Support: Hiroshima University