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

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Completed

CT.gov ID

NCT03545009

Collaborator

(none)

Enrollment

Location

Arms

24.7

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Disease Obesity Exercise	Dietary Supplement: Sodium Nitrate Dietary Supplement: Beetroot Juice no Nitrate Dietary Supplement: Beetroot Juice	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

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

Actual Study Start Date :

Aug 10, 2018

Actual Primary Completion Date :

Aug 30, 2020

Actual Study Completion Date :

Aug 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
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
No Intervention: Control

Outcome Measures

Primary Outcome Measures

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gordon Fisher, Associate Professor, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT03545009

Other Study ID Numbers:

300001210

First Posted:

Jun 4, 2018

Last Update Posted:

Sep 22, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Obesity

Metabolic Diseases

Study Results

No Results Posted as of Sep 22, 2021