NCT05835401

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 17, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 18, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

9 months

First QC Date

April 18, 2023

Last Update Submit

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)

EXPERIMENTAL

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

Dietary Supplement: Beetroot juice rich in nitrate

Placebo (Beetroot juice without NO3)

PLACEBO COMPARATOR

Acute ingestion of beetroot juice rich depleted in NO3.

Dietary Supplement: Beetroot juice depleted in nitrate

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.

Experimental (Beetroot juice NO3)

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.

Placebo (Beetroot juice without NO3)

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

Cardiovascular Abnormalities

Interventions

Nitrates

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

AnionsIonsElectrolytesInorganic ChemicalsNitric AcidNitrogen CompoundsOrganic Chemicals

Study Officials

  • Cicero Jonas Rodrigues Benjamim, PhD Student

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

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

Locations