Effects of Dietary Nitrate Intake on Cardiovascular Performance in Response to Hand Grip Test in Bodybuilders
1 other identifier
interventional
13
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2023
Shorter than P25 for not_applicable
1 active site
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
Study Start
First participant enrolled
April 17, 2023
CompletedFirst Submitted
Initial submission to the registry
April 18, 2023
CompletedFirst Posted
Study publicly available on registry
April 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJuly 28, 2025
July 1, 2025
9 months
April 18, 2023
July 23, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
1. Values of systolic and diastolic blood pressure (mmHg)
up to 2 years
Secondary Outcomes (5)
Plasmatic concentrations of nitrate and nitrite (mmol/L)
up to 2 years
Values of heart rate variability (ms)
up to 2 years
Macrovascular function (Flow mediated dilatation%)
up to 2 years
Values of heart rate (beats per minute)
up to 2 years
Values of hand grip strength (kgF)
up to 2 years
Study Arms (2)
Experimental (Beetroot juice NO3)
EXPERIMENTALAcute ingestion of beetroot juice rich in NO3 (800mg).
Placebo (Beetroot juice without NO3)
PLACEBO COMPARATORAcute ingestion of beetroot juice rich depleted in NO3.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Anabolic steroid use in the past or actually;
- Participation at least one bodybuilding competition;
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
EEFERP - USP / Laboratório de Fisiologia do Exercício e Metabolismo
Ribeirão Preto, São Paulo, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cicero Jonas Rodrigues Benjamim, PhD Student
University of Sao Paulo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
April 18, 2023
First Posted
April 28, 2023
Study Start
April 17, 2023
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
July 28, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share