Beetroot Supplementation and High Intensity Exercise

April 7, 2024 updated by: Stephen Burns, Nanyang Technological University

The Effect of Isotonic Beetroot Supplementation on High-intensity Time-trial Performance

Ingested beetroot contains inorganic nitrate which is later converted to nitric oxide (NO) in the bloodstream. NO is an important signaling molecule with several physiological functions in the body including acting as a vasodilator, expanding arteries and improving blood flow. Beetroot juice contain inorganic nitrate and consumption of beetroot has been shown to improve skeletal muscle contractility and metabolism enhancing high-intensity exercise performance. Isotonic sports drinks contain carbohydrates and sodium, which also improve exercise performance by providing exogenous glucose for energy to the working muscle and central nervous system and enabling faster absorption of fluid into the bloodstream. The ingestion of exogenous nitrate and isotonic-carbohydrate drink are recognized strategies for promoting exercise performance but whether they can be effectively combined has not been shown. This study will compare the salivary nitrite response, muscle oxygenation and time-trial performance after ingestion of two isotonic drinks with high in nitrate or with no nitrate.

Study Overview

Status

Status

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

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

Ingested beetroot contains inorganic nitrate (NO3-) which is later converted to nitric oxide (NO) in the bloodstream. NO is an important signaling molecule with several physiological functions in the body including acting as a vasodilator, expanding arteries and improving blood flow. These functions mean that beetroot juice has become of strong interest in the field of exercise and is a recommended supplement for athletes to improve performance in recent consensus statements by the International Olympic Committee on dietary supplements. Importantly, the consumption of beetroot has been shown to improve skeletal muscle contractility and metabolism, hence, enhancing high-intensity exercise performance . Isotonic sports drinks contain carbohydrates and sodium, which also improve exercise performance by providing exogenous glucose for energy to the working muscle and central nervous system and enabling faster absorption of fluid into the bloodstream. The ingestion of exogenous nitrate and isotonic-carbohydrate drink are recognized strategies for promoting exercise performance but whether they can be effectively combined has not been shown. This study will compare the salivary nitrite response, muscle oxygenation and time-trial performance after ingestion of two drinks either high in nitrate or with no nitrate. Participants will ingest the two drinks in a randomised, crossover double-blind trial. One hour after drink ingestion they will undertake high intensity intermittent exercise for 30 minutes followed by a 10 km time trial on a cycle ergometer. Time trial will be compared between trials as the main outcome. It is hypothesised that the drink high in nitrate will lead to faster time trial completion.

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 (Actual)

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.
24

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 Locations

  • Singapore
      • Singapore, Singapore, 637616
        • Human Bioenergetics Laboratory, National Institute of Education, Nanyang Technological University

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age: 21 - 40 years
  • Healthy and injury-free (e.g., no cardiovascular disease, diabetes mellitus, orthopaedic impairment that interferes with moderate-to-vigorous exercise)
  • Blood pressure < 130/90 mmHg
  • Physically active: Engaging in a minimum of 150 minutes of moderate-intensity exercise or 75 minutes of vigorous-intensity physical activity each week.
  • Recreational cyclist (Minimum 1 hour cycling per week)
  • Body mass index: 18.5-25 kg/m2
  • Non-smoker
  • Asian ethnicity by self identification

Exclusion Criteria:

  • Any allergies to beetroot or isotonic drink.
  • Asthma.
  • Any report of personal health issues that may compromise the individual's ability to undertake exercise safely.
  • Any recent Covid vaccination (within last 2 weeks).

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: Other
  • 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.
Experimental: High nitrate
High nitrate isotonic drink
Dietary supplement: High nitrate isotonic drink
High nitrate (12.9 mmol) drink with carbohydrate and minerals
Active Comparator: No nitrate
No nitrate isotonic drink
Dietary supplement: No nitrate isotonic drink
Carbohydrate and mineral isotonic drink

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
10 km cycling time trial (endurance) performance
Time Frame: 1 hour after drink ingestion the time taken to complete 10 km on a stationary cycle ergometer will be assessed. Time to complete this is the primary outcome measure .
Time trial
1 hour after drink ingestion the time taken to complete 10 km on a stationary cycle ergometer will be assessed. Time to complete this is the primary outcome measure .

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Salivary nitrate
Time Frame: Four samples over 2 hours
Salivary nitrate concentration determined from strips
Four samples over 2 hours
Near infra-red spectroscopy (NIRS)
Time Frame: During cycling ~1 hour
Tissue saturation index
During cycling ~1 hour

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.
Nanyang Technological University

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: Stephen Burns, PhD, Nanyang Technological University

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.
March 15, 2023

Primary Completion (Actual)

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.
March 14, 2024

Study Completion (Actual)

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.
March 14, 2024

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).
April 11, 2023

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.
April 23, 2023

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.
May 3, 2023

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.
April 9, 2024

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.
April 7, 2024

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.
April 1, 2024

More Information

Terms related to this study

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.
  • IRB-2022-880

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All published data will be placed into the Data Repository of Nanyang Technological University National Institute of Education for public access upon publication.

IPD Sharing Time Frame

Upon publication - permanent repository

IPD Sharing Access Criteria

Public repository - exact web address available upon publication.

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

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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