NCT03545009

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 4, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

August 10, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
Last Updated

September 22, 2021

Status Verified

September 1, 2021

Enrollment Period

2.1 years

First QC Date

May 22, 2018

Last Update Submit

September 20, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to Exhaustion

    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.

Study Arms (4)

Beetroot Juice

EXPERIMENTAL
Dietary Supplement: Beetroot Juice

Beetroot Juice no Nitrate

ACTIVE COMPARATOR
Dietary Supplement: Beetroot Juice no Nitrate

Sodium Nitrate

ACTIVE COMPARATOR
Dietary Supplement: Sodium Nitrate

Control

NO INTERVENTION

Interventions

Sodium NitrateDIETARY_SUPPLEMENT

70ml sodium nitrate, matched for nitrate concentration in Beetroot Juice arm

Sodium Nitrate
Beetroot Juice no NitrateDIETARY_SUPPLEMENT

70ml Concentrated Beetroot Juice with nitrate removed

Beetroot Juice no Nitrate
Beetroot JuiceDIETARY_SUPPLEMENT

70ml Concentrated Beetroot Juice

Beetroot Juice

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Metabolic DiseasesObesityMotor Activity

Interventions

sodium nitrate

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Gordon Fisher, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 22, 2018

First Posted

June 4, 2018

Study Start

August 10, 2018

Primary Completion

August 30, 2020

Study Completion

August 30, 2020

Last Updated

September 22, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations