Determination of the Independent Effects of Beetroot Juice Components, Dietary Nitrate and Antioxidants, on Exercise Tolerance and Health Benefits in Individuals With Obesity (BEETIT)

September 20, 2021 updated by: Gordon Fisher, University of Alabama at Birmingham
The purpose of this study is to assess the effects of acute beetroot juice supplementation on exercise performance and cardiometabolic health in obese individuals with secondary cardiometabolic complications. Additionally, we will determine if the ergogenic health benefits of beetroot juice is due to the nitric oxide compound within the product, the antioxidant compound within the product, or a combination of the two compounds.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • 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 Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham

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

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI ≥ 30 kg/m2
  • Able to perform exercise testing on a cycle ergometer

Exclusion Criteria:

  • Currently taking medications know to affect cardiovascular or respiratory function
  • Currently supplementing with an antioxidant compound
  • Current smoker
  • Currently taking antibiotics
  • Not willing to abstain from mouthwash use
  • Currently participating in regular physical activity

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Beetroot Juice
Dietary supplement: Beetroot Juice
70ml Concentrated Beetroot Juice
Active Comparator: Beetroot Juice no Nitrate
Dietary supplement: Beetroot Juice no Nitrate
70ml Concentrated Beetroot Juice with nitrate removed
Active Comparator: Sodium Nitrate
Dietary supplement: Sodium Nitrate
70ml sodium nitrate, matched for nitrate concentration in Beetroot Juice arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to Exhaustion
Time Frame: A Time to Exhaustion Test will be conducted on each participant a total of four times throughout their participation in the study. This will take place approximately 2.5 hours post ingestion of the dietary supplement they are randomized to at each visit.
A Time to Exhaustion Test will be conducted on each participant a total of four times throughout their participation in the study. This will take place approximately 2.5 hours post ingestion of the dietary supplement they are randomized to at each visit.

Collaborators and Investigators

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

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Gordon Fisher, PhD, University of Alabama at Birmingham

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)

August 10, 2018

Primary Completion (Actual)

August 30, 2020

Study Completion (Actual)

August 30, 2020

Study Registration Dates

First Submitted

May 22, 2018

First Submitted That Met QC Criteria

May 22, 2018

First Posted (Actual)

June 4, 2018

Study Record Updates

Last Update Posted (Actual)

September 22, 2021

Last Update Submitted That Met QC Criteria

September 20, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 300001210

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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