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

Primary Purpose

Steroid Abuse, Cardiovascular Abnormalities

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Beetroot juice rich in nitrate
Beetroot juice depleted in nitrate
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Steroid Abuse

Eligibility Criteria

18 Years - 45 Years (Adult)MaleDoes not accept healthy volunteers

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).

Sites / Locations

  • EEFERP - USP / Laboratório de Fisiologia do Exercício e MetabolismoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental (Beetroot juice NO3)

Placebo (Beetroot juice without NO3)

Arm Description

Acute ingestion of beetroot juice rich in NO3 (800mg).

Acute ingestion of beetroot juice rich depleted in NO3.

Outcomes

Primary Outcome Measures

Macrovascular function (Flow mediated dilatation%)

Secondary Outcome Measures

Plasmatic concentrations of nitrate and nitrite (mmol/L)
Values of systolic and diastolic blood pressure (mmHg)
Values of heart rate variability (ms)
Values of heart rate (beats per minute)
Values of hand grip strength (kgF)

Full Information

First Posted
April 18, 2023
Last Updated
April 18, 2023
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT05835401
Brief Title
Effects of Dietary Nitrate Intake on Cardiovascular Performance in Response to Hand Grip Test in Bodybuilders
Official Title
Effects of Dietary Nitrate Intake on Cardiovascular Performance in Response to Hand Grip Test in Bodybuilders
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Steroid Abuse, Cardiovascular Abnormalities

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental (Beetroot juice NO3)
Arm Type
Experimental
Arm Description
Acute ingestion of beetroot juice rich in NO3 (800mg).
Arm Title
Placebo (Beetroot juice without NO3)
Arm Type
Placebo Comparator
Arm Description
Acute ingestion of beetroot juice rich depleted in NO3.
Intervention Type
Dietary Supplement
Intervention Name(s)
Beetroot juice rich in nitrate
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Beetroot juice depleted in nitrate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Macrovascular function (Flow mediated dilatation%)
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
Plasmatic concentrations of nitrate and nitrite (mmol/L)
Time Frame
up to 2 years
Title
Values of systolic and diastolic blood pressure (mmHg)
Time Frame
up to 2 years
Title
Values of heart rate variability (ms)
Time Frame
up to 2 years
Title
Values of heart rate (beats per minute)
Time Frame
up to 2 years
Title
Values of hand grip strength (kgF)
Time Frame
up to 2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cicero Jonas Rodrigues Benjamim, PhD Student
Phone
+5516981462620
Email
jonasbenjamim@usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos Bueno Jr., PhD
Phone
+5516981462620
Email
buenojr@usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cicero Jonas Rodrigues Benjamim, PhD Student
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
EEFERP - USP / Laboratório de Fisiologia do Exercício e Metabolismo
City
Ribeirão Preto
State/Province
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cicero Jonas R. Benjamim, PhD Student
Phone
87988621194
Email
benjamim.nutricao@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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