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

May 14, 2026 updated by: Universidade Federal Fluminense

Effects of Beetroot Extract Supplementation Associated With an Exercise Protocol on Oxidative Stress, Inflammation, and Functional Capacity in Patients With Chronic Kidney Disease

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is an acute and chronic study, the acute type being a randomized, double-blind, crossover clinical trial with a washout period and placebo-controlled trial (RCT), and the chronic concerns a randomized, double-blind, placebo-controlled clinical trial type study (randomized controlled trial - RCT). To calculate the sample size, it was assumed that the tumor necrosis factor (TNF)-alpha concentration would decrease by 1.0 pg/mL after intervention with beetroot juice using the within-patient standard deviation of 2.3. It was assumed a type I error of P < 0.05 and a test power of 80%, and it was estimated that, for both the acute and chronic study, 25 patients would be needed (margin of 10%, 28 patients) with CKD undergoing conservative treatment at the Renal Nutrition Outpatient Clinic. Eligible patients of both genders, previously evaluated and authorized by the medical and nutritionist staff, will be invited to participate in the research in person and verbally, during nutritional consultations at the Renal Nutrition Outpatient Clinic. The acute intervention study will be divided into 3 stages. The first stage will consist of collecting anthropometric data, food intake, completion of individual quality of life questionnaires (SF-36) and physical activity level (IPAQ) and, finally, familiarization with the exercise protocol that will be carried out in the following stages. Already in second stage, initial data will be collected from participants, soon after, participantes will be invited to perform the 6-minute walk test. Then, all individuals will be instructed to ingest beetroot juice or placebo and wait for at least 2 hours. After 2 hours, all volunteers must complete the training protocol lasting 20 minutes. At the end of the exercises, both groups will be reevaluated. Finally, in the third and final stage, after 14 washout days participants will go through the same process described in the previous stage, however, participantes will carry out the opposite intervention to that carried out in stage two, that is, those who participated in the beetroot juice group will become part of the control group and vice versa. The chronic intervention study will be similar to the acute intervention stages, but individuals will undergo three weekly sessions, totaling 24 training sessions (8 weeks), without washout period. The second stage will begin with the collection of blood samples and vital data of participants, as well as the performance. For eight weeks, volunteers will ingest beetroot juice or control and, after 2 hours of rest, they must perform the protocol of circuit exercises. The end of this stage will be characterized by the collection of blood, vital signs, data on food intake, clinical, anthropometric, filling out questionnaires (SF-36 and IPAC) and carrying out. Before and after training, each practitioner's vital signs will be measured by security measure. If the resting heart rate is greater than 120 beats per minute (bpm), systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 100 mmHg, the patient will be contraindicated to perform the day's training. Training should also be stopped if the subject presents chest pain, dyspnea, lower leg cramps, staggering gait, intense sweating and paleness, recommendations that will also be adopted to perform.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Brazil
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brazil, 22260050
        • Recruiting
        • Denise Mafra
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Intervention
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
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.
Placebo Comparator: Placebo
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change individual quality of life
Time Frame: 8 weeks
Qualitative parameter
8 weeks
Change physical activity level
Time Frame: 8 weeks
Qualitative parameter
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Federal Fluminense

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Denise Mafra, PhD, Associate Professor - Universidade Federal Fluminense

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 10, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 10, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 10, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DeniseMafra19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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