Hypertensive Heart Disease Without (Congestive) Heart FailureNCT07270718
The Influence of Beetroot Powder at a Dose of 20 g on Blood Pressure, Microcirculation, and Biochemical Markers in Men With Arterial Hypertension.SVEKLA2025.
A study testing Plus SVEKLA in people with Hypertensive Heart Disease Without (Congestive) Heart Failure, run by National Medical Research Center for Therapy and Preventive Medicine at 1 site in Russia.
Trial summary
Objective: to evaluate the effectiveness of using a food product, dry finely dispersed beetroot powder in a dose of 20 g, containing 800 mg of nitrate (NO3-), in relation to the regulation of blood pressure in men with hypertension who reached the target blood pressure level while taking optimal antihypertensive… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertensive Heart Disease Without (Congestive) Heart Failure
- What is being tested?
- Plus SVEKLA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- 24 Jan 2025to Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- A history of hypertension with achievement of the target blood pressure level according to the SMAD while taking regular AGT;
- signing informed consent to participate in the study.
Who cannot join
- coronary heart disease, including angina pectoris and myocardial infarction; cerebrovascular disease, including acute cerebrovascular accident and transient ischemic attack; obliterating atherosclerosis of peripheral vessels, revascularization in any vascular basin; cardiomyopathy; secondary forms of hypertension; type 1 or 2 diabetes mellitus, impaired glucose tolerance; inflammatory bowel diseases; organ transplantation; oncological, mental illnesses; diffuse connective tissue diseases in the anamnesis;
- BMI ≥30 kg/m2;
- symptoms of heart failure;
- acute infectious diseases at the time of inclusion in the study and within 1 month prior to inclusion in the study;
- Exacerbation of chronic non-communicable diseases;
- alcoholism, taking narcotic drugs;
- allergic and undesirable reactions to foods containing beetroot and egg white in the anamnesis;
- refusal to continue participating in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
National Medical Research Center for Preventive Medicine
Moscow, 101990
Kamila S. Samatova, MD, MS, +7 987-388-3655, kamilasamatova@rambler.ru
About this study
Objective: to evaluate the effectiveness of using a food product, dry finely dispersed beetroot powder in a dose of 20 g, containing 800 mg of nitrate (NO3-), in relation to the regulation of blood pressure in men with hypertension who reached the target blood pressure level while taking optimal antihypertensive therapy.
Characteristics of the study: randomized, open, and cross-sectional. Relevance of the study Currently, it is recognized that vasodilatory endothelial dysfunction due to impaired synthesis and bioavailability of endogenous nitric oxide (NO) is a characteristic change in patients with arterial hypertension (AH) and plays one of the key roles in the development and progression of this pathology.
Read more
Nitrate (NO3-), contained in food products, the highest content of which is found in beetroot, is converted into NO in the body after consumption, which can have a positive effect on the state of the cardiovascular system and lead to a decrease in blood pressure. Indeed, this assumption has been confirmed in various clinical studies. The results of the conducted studies demonstrate the positive effect of beetroot juice enriched with NO3- on the functional parameters of the cardiovascular system, in particular, the level of SAD and DBP, vasodilator function, endothelium and arterial stiffness, both in patients with hypertension and conditionally healthy people.
However, most of the studies conducted in this field either include a relatively small number of subjects with hypertension, or do not have a cross-sectional design, which is a limitation in formulating unambiguous conclusions about the positive effect of taking beetroot enriched with NO3- on lowering blood pressure in this category of patients. Moreover, the effect of beetroot juice on the functional state of the peripheral arterial bed (terminal muscular arteries, distributive and precapillary arterioles) remains unexplored, which, due to the increased bioavailability of NO by the vascular wall, may be expressed in a decrease in arterial stiffness, a decrease in smooth muscle cell tone (MMC) and a decrease in total peripheral vascular resistance, which will have a positive effect on tissue homeostasis. It is relevant to study the effect of course intake of beetroot enriched with NO3- on the functional state of all arterial links and regulation of blood pressure in patients with hypertension.
Research materials and methods The study will be performed on the basis of the Laboratory of Microcirculation and Regional Blood Circulation of the Department of Fundamental and Applied Aspects of Obesity and the Center for Coordination of Fundamental Scientific Activities of the Federal State Budgetary Institution "NMIC TPM" of the Ministry of Health of the Russian Federation. The study is planned to include 60 men aged 18-60 years with hypertension who reached the target blood pressure level according to office measurement and daily blood pressure monitoring (SMAD) on the background of regular intake of AGT.
Research design The study will consist of two screening stages and one main stage (Figure 1). Patients will be divided into 2 equal groups of 30 men using simple randomization using the closed envelope method. The first group will be assigned a one-week course of daily intake of dry fine beetroot powder in a dose of 20 g containing 800 mg of NO3- (food product), the second group will continue regular intake of AGT. After 7 days, the crossing will be performed: patients of the first group will continue to receive regular AGT, and patients of the second group will receive a food product. At each stage, all participants undergo blood pressure and heart rate (HR) measurements, anthropometry, basic research methods* and SMAD. The total duration of the study will be 14-16 days.
- Being tested
- Plus SVEKLA
- Keywords
- exogenous nitrate, nitric oxide, blood pressure, endothelial dysfunction, beetroot
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plus SVEKLADietary supplement
The first time in the Russian Federation beetroot powder (20 g equivalent 800 mg NOx) in clinical trial in patients with hypotension disease
| Study group | Role | What they receive |
|---|---|---|
| Plus SVEKLA | Experimental | Powder SVEKLA 20 g (800 mg NOx) Receives: Dietary Supplement: Plus SVEKLA |
| No SVEKLA | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure decrease
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start24 Jan 2025
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive Heart Disease Without (Congestive) Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Medical Research Center for Therapy and Preventive Medicine
- Sponsor type
- Other government
- Collaborators
- Saratov State Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270718
- Sponsor's protocol ID
- 01-07/24
- Status last verified
- Sep 2025
- First submitted
- 26 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No