Steroid AbuseNCT05835401
Effects of Dietary Nitrate Intake on Cardiovascular Performance in Response to Hand Grip Test in Bodybuilders
A study testing Beetroot juice rich in nitrate and Beetroot juice depleted in nitrate in people with Steroid Abuse and Cardiovascular Abnormalities, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Steroid Abuse, Cardiovascular Abnormalities
- What is being tested?
- Beetroot juice rich in nitrate and Beetroot juice depleted in nitrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteBrazil
- Study dates
- 17 Apr 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Anabolic steroid use in the past or actually;
- Participation at least one bodybuilding competition;
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Brazil1 site
EEFERP - USP / Laboratório de Fisiologia do Exercício e Metabolismo
Ribeirão Preto, São Paulo
About this study
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.
- Conditions
- Steroid Abuse, Cardiovascular Abnormalities
- Being tested
- Beetroot juice rich in nitrate, Beetroot juice depleted in nitrate
- Medical subject headings
- Cardiovascular Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot juice rich in nitrateDietary supplement
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 nitrateDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental (Beetroot juice NO3) | Experimental | Acute ingestion of beetroot juice rich in NO3 (800mg). Receives: Dietary Supplement: Beetroot juice rich in nitrate |
| Placebo (Beetroot juice without NO3) | Placebo comparator | Acute ingestion of beetroot juice rich depleted in NO3. Receives: Dietary Supplement: Beetroot juice depleted in nitrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Values of systolic and diastolic blood pressure (mmHg)
Measured: up to 2 years
Secondary outcomes (5)
Plasmatic concentrations of nitrate and nitrite (mmol/L)
Measured: up to 2 years
Values of heart rate variability (ms)
Measured: up to 2 years
Macrovascular function (Flow mediated dilatation%)
Measured: up to 2 years
Values of heart rate (beats per minute)
Measured: up to 2 years
Values of hand grip strength (kgF)
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start17 Apr 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Steroid AbuseStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cicero Jonas R Benjamim, University of Sao Paulo
- Investigators
- Cicero Jonas Rodrigues Benjamim, PhD Student, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835401
- Sponsor's protocol ID
- BodyBeet
- Status last verified
- Jul 2025
- First submitted
- 18 Apr 2023
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dietary Nitrate Intake on Cardiovascular Performance in Response to Hand Grip Test in Bodybuilders
- ClinicalTrials.gov ID
- NCT05835401
- Acronym / sponsor ID
- BodyBeet
- Conditions
- Steroid Abuse, Cardiovascular Abnormalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental (Beetroot juice NO3) | Experimental | Dietary Supplement: Beetroot juice rich in nitrateAcute ingestion of beetroot juice rich in NO3 (800mg). |
| Placebo (Beetroot juice without NO3) | Placebo comparator | Dietary Supplement: Beetroot juice depleted in nitrateAcute ingestion of beetroot juice rich depleted in NO3. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Anabolic steroid use in the past or actually;
- Participation at least one bodybuilding competition;
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beetroot juice rich in nitrateThe 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. | Dietary supplement | Experimental (Beetroot juice NO3) |
| Beetroot juice depleted in nitrateThe 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. | Dietary supplement | Placebo (Beetroot juice without NO3) |
Primary outcome
1. Values of systolic and diastolic blood pressure (mmHg)
Time frame: up to 2 years
5 secondary outcomes
Plasmatic concentrations of nitrate and nitrite (mmol/L)
Time frame: up to 2 years
Values of heart rate variability (ms)
Time frame: up to 2 years
Macrovascular function (Flow mediated dilatation%)
Time frame: up to 2 years
Values of heart rate (beats per minute)
Time frame: up to 2 years
Values of hand grip strength (kgF)
Time frame: up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Steroid Abuse
Not yet recruiting
Harm Reduction Intervention for Anabolic-androgenic Steroids Users: a Randomized Controlled Trial
Drug Abuse, Harm Reduction
Active, not recruiting
CBT for Muscle Dysmorphia and Steroid Abuse: A Randomized Controlled Trial
Body Dysmorphic Disorder, Steroid Abuse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cicero Jonas Rodrigues Benjamim, PhD Student principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beetroot juice rich in nitrate and Beetroot juice depleted in nitrate in people with Steroid Abuse and Cardiovascular Abnormalities, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Values of systolic and diastolic blood pressure (mmHg) (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.