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

Primary Purpose

Metabolic Disease, Obesity, Exercise

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sodium Nitrate
Beetroot Juice no Nitrate
Beetroot Juice
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metabolic Disease

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

No Intervention

Arm Label

Beetroot Juice

Beetroot Juice no Nitrate

Sodium Nitrate

Control

Arm Description

Outcomes

Primary Outcome Measures

Time to Exhaustion

Secondary Outcome Measures

Full Information

First Posted
May 22, 2018
Last Updated
September 20, 2021
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03545009
Brief Title
Determination of the Independent Effects of Beetroot Juice Components, Dietary Nitrate and Antioxidants, on Exercise Tolerance and Health Benefits in Individuals With Obesity
Acronym
BEETIT
Official Title
Determination of the Independent Effects of Beetroot Juice Components, Dietary Nitrate and Antioxidants, on Exercise Tolerance and Health Benefits in Individuals With Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 10, 2018 (Actual)
Primary Completion Date
August 30, 2020 (Actual)
Study Completion Date
August 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Disease, Obesity, Exercise

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Beetroot Juice
Arm Type
Experimental
Arm Title
Beetroot Juice no Nitrate
Arm Type
Active Comparator
Arm Title
Sodium Nitrate
Arm Type
Active Comparator
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Sodium Nitrate
Intervention Description
70ml sodium nitrate, matched for nitrate concentration in Beetroot Juice arm
Intervention Type
Dietary Supplement
Intervention Name(s)
Beetroot Juice no Nitrate
Intervention Description
70ml Concentrated Beetroot Juice with nitrate removed
Intervention Type
Dietary Supplement
Intervention Name(s)
Beetroot Juice
Intervention Description
70ml Concentrated Beetroot Juice
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gordon Fisher, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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