UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056207 |
|---|---|
| Receipt number | R000064220 |
| Scientific Title | Effects of Beetroot Juice Intake on Vascular Function in Hypertensive Patients on Antihypertensive Treatment |
| Date of disclosure of the study information | 2024/11/20 |
| Last modified on | 2024/11/20 09:57:28 |
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Basic information
Public title
Effects of Beetroot Juice Intake on Vascular Function in Hypertensive Patients on Antihypertensive Treatment
Acronym
Beetroot Juice and Vascular Function
Scientific Title
Effects of Beetroot Juice Intake on Vascular Function in Hypertensive Patients on Antihypertensive Treatment
Scientific Title:Acronym
Beetroot Juice and Vascular Function
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effectiveness of nitrate intake on endothelial function in hypertensive patients on antihypertensive treatment. Specifically, the study will compare the changes in flow-mediated vasodilation (FMD) after 4 weeks of consuming beetroot juice containing nitrates versus a placebo juice, which has the nitrates removed, in hypertensive patients on antihypertensive medication.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The average change in FMD before and after 4 weeks of consuming beetroot juice or placebo juice.
Key secondary outcomes
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.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
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.
Interventions/Control_2
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Individuals aged 18 years or older at the time of obtaining consent.
2. Patients diagnosed with hypertension according to the JSH2019 criteria (office blood pressure: systolic blood pressure greater than or equal to 140 mmHg and/or diastolic blood pressure greater than or equal to 90 mmHg, or home blood pressure: systolic blood pressure greater than or equal to 135 mmHg and/or diastolic blood pressure greater than or equal to 85 mmHg), who have been on the same antihypertensive treatment for at least 3 months.
3. Individuals who are able to attend four visits every 4 weeks.
4. Individuals who can provide written informed consent for participation in this study.
Key exclusion 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.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yukihito |
| Middle name | |
| Last name | Higashi |
Organization
Hiroshima University Hospital
Division name
Division of Regeneration and Medicine, Medical Center for Translational and Clinical Research
Zip code
7348553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
0822575831
yhigashi@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Maruhashi |
Organization
Hiroshima University
Division name
Department of Regenerative Medicine, Division of Radiation Medical Science, Research Institute for R
Zip code
7438551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
0822575831
Homepage URL
maru0512@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-Ku, Hiroshima
Tel
082-257-1947
iryo-sinsa@office.hiroshima-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 20 | Day |
Last modified on
| 2024 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064220
