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

Cardiovascular Abnormalities Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05835401
• Other study ID #: BodyBeet
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: University of Sao Paulo
• Contact: Cicero Jonas Rodrigues Benjamim, PhD Student
• Phone: +5516981462620
• Email: jonasbenjamim[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cardiovascular Abnormalities

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	EEFERP - USP / Laboratório de Fisiologia do Exercício e Metabolismo	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Macrovascular function (Flow mediated dilatation%)		up to 2 years
Secondary	Plasmatic concentrations of nitrate and nitrite (mmol/L)		up to 2 years
Secondary	Values of systolic and diastolic blood pressure (mmHg)		up to 2 years
Secondary	Values of heart rate variability (ms)		up to 2 years
Secondary	Values of heart rate (beats per minute)		up to 2 years
Secondary	Values of hand grip strength (kgF)		up to 2 years