NCT06286748 Beetroot Extract Supplementation Associated With an Exercise Protocol for Chronic Kidney Disease Patients
| NCT ID | NCT06286748 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidade Federal Fluminense |
| Condition | Chronic Kidney Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2024-04-10 |
| Primary Completion | 2026-11-10 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2024-04-10 with a primary completion date of 2026-11-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Chronic kidney disease (CKD) patients often present systemic inflammation and oxidative stress, resulting in metabolic disorders and high rates of disease-associated cardiovascular death. The literature has indicated that dietary control, the use of bioactive compounds, and the practice of regular physical exercise are essential for the prevention and management of CKD and its complications. In this context, beetroot (Beta vulgaris rubra) deserves attention as it is a source of several bioactive compounds, such as nitrate, betaine, and betalain, with beneficial effects for CKD patients, including anti-inflammatory, antioxidant effects, reduction of blood pressure, and vasodilatory action. The antioxidant and anti-inflammatory properties, in addition to their vasodilatory and antihypertensive capacity, can make supplementation of beetroot an excellent nutritional strategy to help in the treatment of CKD patients. So, this research project will bring contributions to the scientific world, providing strategies for application in clinical practice and the care of patients with CKD, on the use of beetroot associated with an exercise protocol as a non-pharmacological strategy in modulating inflammation, oxidative stress, and improved functional capacity. Furthermore, when supplemented hours before physical training, has been identified as an important factor in improving performance in these activities. Therefore, this study aims to evaluate the effects of supplementation (acute and chronic) of beetroot extract associated with an exercise protocol on complications associated with CKD.
Eligibility Criteria
Inclusion Criteria: * Patients with CKD undergoing conservative treatment (stages G3a-G4); * Aged between 18 and 65 years old; * Patients undergoing nutritional monitoring for more than 6 months. Exclusion Criteria: * Patients using catabolic drugs; * Smokers * Pregnant women; * Using antibiotics and of proton pump inhibitors in the last 3 months; * Antioxidant supplements and habitual intake of beetroot or nitrate supplement; * Those who are clinically unstable (unstable angina, atrial fibrillation, significant cardiac arrhythmia and acute illness in the last month; and glycemic lability); * Unable to exercise (amputation without prosthesis); musculoskeletal pain at rest or with minimal physical activity, inability to sit or walk without assistance, use of a walking device, dyspnea at rest or with light exertion; * Those with autoimmune diseases and infectious diseases, cancer, liver disease and AIDS. * Patients with parathormone (PTH) levels above 500pg/mL; * Those who are allergic or intolerant to the components of the juice. * Patients with any impediment to completing the proposed exercise protocol, such as due to travel or difficulty accessing the location where the research will be carried out.
Contact & Investigator
Denise Mafra, PhD
PRINCIPAL INVESTIGATOR
Associate Professor - Universidade Federal Fluminense
Frequently Asked Questions
Who can join the NCT06286748 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Chronic Kidney Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06286748 currently recruiting?
Yes, NCT06286748 is actively recruiting participants. Contact the research team at dmafra30@gmail.com for enrollment information.
Where is the NCT06286748 trial being conducted?
This trial is being conducted at Rio de Janeiro, Brazil.
Who is sponsoring the NCT06286748 clinical trial?
NCT06286748 is sponsored by Universidade Federal Fluminense. The principal investigator is Denise Mafra, PhD at Associate Professor - Universidade Federal Fluminense. The trial plans to enroll 25 participants.
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