Effects of Dietary Nitrate Intake on Cardiovascular Performance in Response to Hand Grip Test in Bodybuilders

Through a randomized, crossover, double-blind, placebo-controlled clinical trial, 20 bodybuilders will participate a acute-day trial with two intervention protocols: 1) placebo and 2) nitrate; in which will ingest beet juice with or without NO3 in its composition with a 7-day washout interval.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Abnormalities; Steroid Abuse
• Intervention / Treatment: Dietary supplement: Beetroot juice rich in nitrate; Dietary supplement: Beetroot juice depleted in nitrate

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cicero Jonas Rodrigues Benjamim, PhD Student; Phone Number: +5516981462620; Email: jonasbenjamim@usp.br
• Study Contact Backup: Name: Carlos Bueno Jr., PhD; Phone Number: +5516981462620; Email: buenojr@usp.br

Study Locations

• Brazil
  • São Paulo
    • Ribeirão Preto, São Paulo, Brazil
      • Recruiting
      • EEFERP - USP / Laboratório de Fisiologia do Exercício e Metabolismo
      • Contact: Cicero Jonas R. Benjamim, PhD Student; Phone Number: 87988621194; Email: benjamim.nutricao@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Anabolic steroid use in the past or actually;
• Participation at least one bodybuilding competition;

Exclusion Criteria:

• Previous history of acute myocardial infarction and/or stroke;
• Allergy or intolerance to nitrate, gluten, or milk;
• Medications (proton pump inhibitors, beta-blockers, calcium channels antagonists).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental (Beetroot juice NO3); Acute ingestion of beetroot juice rich in NO3 (800mg).	Dietary supplement: Beetroot juice rich in nitrate; The participant will intake beetroot juice rich in NO3 (800mg). Two hours after intake the last bottle of juice, the participants will go to the laboratory for the handgrip and cardiovascular tests evaluation. Before crossover protocol a 7-day washout interval will be given for the purification of the compounds provided by the protocols.
Placebo Comparator: Placebo (Beetroot juice without NO3); Acute ingestion of beetroot juice rich depleted in NO3.	Dietary supplement: Beetroot juice depleted in nitrate; The participant will intake beetroot juice depleted in NO3. Two hours after intake the last bottle of juice, the participants will go to the laboratory for the handgrip and cardiovascular tests evaluation. Before crossover protocol a 7-day washout interval will be given for the purification of the compounds provided by the protocols.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Macrovascular function (Flow mediated dilatation%)	up to 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Values of heart rate variability (ms)	up to 2 years
Values of systolic and diastolic blood pressure (mmHg)	up to 2 years
Values of heart rate (beats per minute)	up to 2 years
Plasmatic concentrations of nitrate and nitrite (mmol/L)	up to 2 years
Values of hand grip strength (kgF)	up to 2 years

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Cicero Jonas Rodrigues Benjamim, PhD Student, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: April 18, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): April 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities
• Other Study ID Numbers: BodyBeet

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