Beetroot Extract Supplementation Associated With an Exercise Protocol for Chronic Kidney Disease Patients

NCT06286748 | Recruiting DMC

• 1 other identifier: DeniseMafra19
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases

Keywords

chronic kidney disease; beetroot; exercise; inflammation; oxidative stress

Outcome Measures

Primary Outcomes (2)

• Change individual quality of life

  Qualitative parameter

  8 weeks

• Change physical activity level

  Qualitative parameter

  8 weeks

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Beetroot juice + exercise. Patients will ingest 200ml of beet juice (Beta vulgaris) containing approximately 300mg of nitrate (NO3-), and after 2 hours they will be instructed to perform an exercise protocol.

Dietary Supplement: Beetroot juice

Placebo

PLACEBO COMPARATOR

Placebo + exercise. Patients will ingest 200ml of placebo (water, without nitrate (NO3-)), and after 2 hours they will be instructed to perform an exercise protocol.

Other: Placebo

Interventions

Beetroot juice DIETARY_SUPPLEMENT

Beetroot juice + exercise. Patients will ingest 200ml of beet juice (Beta vulgaris) containing approximately 300mg of nitrate (NO3-), and after 2 hours they will be instructed to perform an exercise protocol.

Intervention

Placebo OTHER

Placebo + exercise. Patients will ingest 200ml of placebo (water, without nitrate (NO3-)), and after 2 hours they will be instructed to perform an exercise protocol.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Denise Mafra

Rio de Janeiro, Rio de Janeiro, 22260050, Brazil

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Motor Activity; Inflammation

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Denise Mafra, PhD

  Associate Professor - Universidade Federal Fluminense

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Denise Mafra, PhD

CONTACT

+5521985683003; dmafra30@gmail.com

Denise Mafra, PhD

CONTACT

5521985683003; dmafra30@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2024
• First Posted: February 29, 2024
• Study Start: April 10, 2024
• Primary Completion: December 10, 2025
• Study Completion (Estimated): December 10, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)