Pulmonary FunctionNCT06073275
Effects of Beetroot Juice Intake on Performance and Physiological Parameters
A study testing Beetroot juice ingestion in people with Pulmonary Function and Nutrition, Healthy, run by Campus docent Sant Joan de Déu-Universitat de Barcelona at 1 site in Spain.
Trial summary
This study was a randomized, double-blind, crossover design for 3 weeks. In the first week, a researcher explained all the experimental procedures to the participants. In the following two weeks, the participants attended the Exercise Physiology laboratory to be assessed in 2 rowing ergometer sessions, separated from… Read more about this study
- Who is it for?
- Ages 30 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Function, Nutrition, Healthy
- What is being tested?
- Beetroot juice ingestion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2018to 26 Feb 2019
- 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 30 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- national and/or international level;
- without cardiovascular, respiratory, metabolic, neurological or orthopedic disorders that may affect the performance of the rowing ergometer test;
- no consumption of drugs or medicines;
- no smoking;
- Informed consent to participate in the study signed by all rowers
Who cannot join
- Ingestion of nutritional supplements taken in the three months prior to the start of the study;
- no following the guidelines established by the nutrition professional.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Campus Docent Sant Joan de Déu. Universitat de Barcelona
Sant Boi de Llobregat, Barcelona, 08830
About this study
Official title: Effects of Acute Beetroot Juice Intake on Performance, Maximal Oxygen Uptake, and Ventilatory Efficiency in Well-trained Master Rowers: A Randomized, Double-blinded Crossover Study
This study was a randomized, double-blind, crossover design for 3 weeks. In the first week, a researcher explained all the experimental procedures to the participants. In the following two weeks, the participants attended the Exercise Physiology laboratory to be assessed in 2 rowing ergometer sessions, separated from each other by a washout period of 7 days, under the same environmental conditions.
In both strictly identical sessions, the participants randomly ingested beetroot juice (BRJ) or placebo (PL) 3 hours before the start of the tests.
Read the detailed description
Three hours after BRJ or PL intake, the participants began the 2,000-meter rowing ergometer test. Before starting (pretest) and at the end of the tests (posttest), blood oxygen saturation, rating of perceived exertion (RPE), and blood lactate measurements were taken. During the rowing ergometer tests, performance parameters and cardiorespiratory variables were recorded.
- Conditions
- Pulmonary Function, Nutrition, Healthy
- Being tested
- Beetroot juice ingestion, Placebo ingestion
- Keywords
- Cardiorespiratory performance, Time trial performance, Beetroot juice, Master rowers, well-trained
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot juice ingestionDietary supplement
Beetroot juice ingestion was randomly administered 3 h before the start of the test to the participants in two assessment sessions with a one-week washout between both sessions.
Placebo ingestionDietary supplement
Placebo ingestion was randomly administered 3 h before the start of the test to the participants in two assessment sessions with a one-week washout between both sessions.
| Study group | Role | What they receive |
|---|---|---|
| Beetroot juice intake | Experimental | Beetroot juice was administered 3 h before the start of the rowing ergometer test since the peak of nitrite in the blood occurs 2-3 h after nitrate ingestion. Beetroot juice was provided in a 140 mL maroon plastic bottle with no label. Participants were provided with a randomized bottle containing 140 mL (~12.8 mmol, ~808 mg of nitrate) of BRJ Beet-It-Pro Elite Shot concentrate (Beet IT; James White Drinks Ltd., Ipswich, UK). Receives: Dietary Supplement: Beetroot juice ingestion |
| Placebo intake | Placebo comparator | Placebo was administered 3 h before the start of the rowing ergometer test. Placebo was provided in a 140 mL maroon plastic bottle with no label. Participants were provided with a randomized bottle containing 140 mL. The placebo drink was made by dissolving in 1 liter of water 2g of powdered SUPER BEETROOT (~ 0.01 mmol, 0.620 mg of nitrate, diet, food, Poland), 100% natural beetroot juice and organic label, and adding lemon juice to imitate the flavor and texture of the beetroot juice drink Receives: Dietary Supplement: Placebo ingestion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rowing performance: Time trial
minutes:seconds (mm:ss)
Measured: through study completion, an average of 3 weeks
Rowing performance: Mean Power output
Watts
Measured: through study completion, an average of 3 weeks
Rowing performance: meter per stroke
Meters
Measured: through study completion, an average of 3 weeks
Cardiorespiratory performance: absolute oxygen uptake
V̇O2max (L/min)
Measured: through study completion, an average of 3 weeks
Cardiorespiratory performance: relative oxygen uptake
V̇O2max (mL/kg/min)
Measured: through study completion, an average of 3 weeks
Cardiorespiratory performance: ventilatory efficiency
slope of Ventilation/Carbon dioxide production
Measured: through study completion, an average of 3 weeks
Metabolic performance: lactate
mmol/L
Measured: through study completion, an average of 3 weeks
Secondary outcomes (6)
Cardiorespiratory performance: Maximum heart rate
beats/min
Measured: through study completion, an average of 3 weeks
Cardiorespiratory performance: Mean heart rate
beats/min
Measured: through study completion, an average of 3 weeks
Saturation
percentage
Measured: through study completion, an average of 3 weeks
Cardiorespiratory performance: minute ventilation
minute ventilation in L/min
Measured: through study completion, an average of 3 weeks
Scale of Perceived exertion ratio (RPE)
Scale from 0 to 10. 0 = rest; 10 = maximum effort
Measured: through study completion, an average of 3 weeks
Rowing performance: strokes
Mean strokes per minute
Measured: through study completion, an average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Nov 2018
- Primary completion31 Jan 2019
- Study completion26 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FunctionStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study was a randomized, double-blind, crossover design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campus docent Sant Joan de Déu-Universitat de Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Vicente Garnacho Castano, Campus docent Sant Joan de Déu-Universitat de Barcelona
- Investigators
- Manuel V Garnacho-Castaño, PhD, Principal investigator, Campus docent Sant Joan de Déu-Universitat de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073275
- Sponsor's protocol ID
- CDSJD
- Status last verified
- Oct 2023
- First submitted
- 25 Sep 2023
- Last updated
- 10 Oct 2023
- 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 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acute Beetroot Juice Intake on Performance, Maximal Oxygen Uptake, and Ventilatory Efficiency in Well-trained Master Rowers: A Randomized, Double-blinded Crossover Study
- ClinicalTrials.gov ID
- NCT06073275
- Acronym / sponsor ID
- CDSJD
- Conditions
- Pulmonary Function, Nutrition, Healthy
- Keywords
- Cardiorespiratory performance, Time trial performance, Beetroot juice, Master rowers, well-trained
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Campus docent Sant Joan de Déu-Universitat de BarcelonaUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 26 Feb 2019 (actual)
- First posted
- 10 Oct 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.
This study was a randomized, double-blind, crossover design for 3 weeks. In the first week, a researcher explained all the experimental procedures to the participants. In the following two weeks, the participants attended the Exercise Physiology laboratory to be assessed in 2 rowing ergometer sessions, separated from each other by a washout period of 7 days, under the same environmental conditions.
In both strictly identical sessions, the participants randomly ingested beetroot juice (BRJ) or placebo (PL) 3 hours before the start of the tests.
Detailed description
Three hours after BRJ or PL intake, the participants began the 2,000-meter rowing ergometer test. Before starting (pretest) and at the end of the tests (posttest), blood oxygen saturation, rating of perceived exertion (RPE), and blood lactate measurements were taken. During the rowing ergometer tests, performance parameters and cardiorespiratory variables were recorded.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study was a randomized, double-blind, crossover design
| Arm | Type | Receives |
|---|---|---|
| Beetroot juice intake | Experimental | Dietary Supplement: Beetroot juice ingestionBeetroot juice was administered 3 h before the start of the rowing ergometer test since the peak of nitrite in the blood occurs 2-3 h after nitrate ingestion. Beetroot juice was provided in a 140 mL maroon plastic bottle with no label. Participants were provided with a randomized bottle containing 140 mL (~12.8 mmol, ~808 mg of nitrate) of BRJ Beet-It-Pro Elite Shot concentrate (Beet IT; James White Drinks Ltd., Ipswich, UK). |
| Placebo intake | Placebo comparator | Dietary Supplement: Placebo ingestionPlacebo was administered 3 h before the start of the rowing ergometer test. Placebo was provided in a 140 mL maroon plastic bottle with no label. Participants were provided with a randomized bottle containing 140 mL. The placebo drink was made by dissolving in 1 liter of water 2g of powdered SUPER BEETROOT (~ 0.01 mmol, 0.620 mg of nitrate, diet, food, Poland), 100% natural beetroot juice and organic label, and adding lemon juice to imitate the flavor and texture of the beetroot juice drink |
Who may qualify
- Ages
- 30 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- national and/or international level;
- without cardiovascular, respiratory, metabolic, neurological or orthopedic disorders that may affect the performance of the rowing ergometer test;
- no consumption of drugs or medicines;
- no smoking;
- Informed consent to participate in the study signed by all rowers
Key exclusion criteria (2 listed)
- Ingestion of nutritional supplements taken in the three months prior to the start of the study;
- no following the guidelines established by the nutrition professional.
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 ingestionBeetroot juice ingestion was randomly administered 3 h before the start of the test to the participants in two assessment sessions with a one-week washout between both sessions. | Dietary supplement | Beetroot juice intake |
| Placebo ingestionPlacebo ingestion was randomly administered 3 h before the start of the test to the participants in two assessment sessions with a one-week washout between both sessions. | Dietary supplement | Placebo intake |
Primary outcome
Rowing performance: Time trial
Time frame: through study completion, an average of 3 weeks
minutes:seconds (mm:ss)
Rowing performance: Mean Power output
Time frame: through study completion, an average of 3 weeks
Watts
Rowing performance: meter per stroke
Time frame: through study completion, an average of 3 weeks
Meters
Cardiorespiratory performance: absolute oxygen uptake
Time frame: through study completion, an average of 3 weeks
V̇O2max (L/min)
Cardiorespiratory performance: relative oxygen uptake
Time frame: through study completion, an average of 3 weeks
V̇O2max (mL/kg/min)
Cardiorespiratory performance: ventilatory efficiency
Time frame: through study completion, an average of 3 weeks
slope of Ventilation/Carbon dioxide production
Metabolic performance: lactate
Time frame: through study completion, an average of 3 weeks
mmol/L
6 secondary outcomes
Cardiorespiratory performance: Maximum heart rate
Time frame: through study completion, an average of 3 weeks
Cardiorespiratory performance: Mean heart rate
Time frame: through study completion, an average of 3 weeks
Saturation
Time frame: through study completion, an average of 3 weeks
Cardiorespiratory performance: minute ventilation
Time frame: through study completion, an average of 3 weeks
Scale of Perceived exertion ratio (RPE)
Time frame: through study completion, an average of 3 weeks
Rowing performance: strokes
Time frame: through study completion, an average of 3 weeks
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 10 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Function
Recruiting
More Than Just X-Rays - Imaging of Chemotherapy-induced Morphological and Functional Cardiovascular and Lung Changes After Childhood ALL and Other Cancers - a Monocentric Late Effects Study (MaximALL)
Acute Lymphatic Leukemia, Lymphoma
Not yet recruiting
Bioimpedance and Multiparametric Ultrasound-Guided Fluid Management After Kidney Transplantation
Kidney Transplantation, Delayed Graft Function
Active, not recruiting
Impact of Lp299v on Vascular Function in Patients With PASC
COVID-19
Not yet recruitingObservational study
Vascular Health and Function in Cystic Fibrosis
Cystic Fibrosis, Endothelial Dysfunction
RecruitingPhase 2
Phase II Clinical Study of Probiotic LR607 in Patients With Non-Small Cell Lung Cancer
NSCLC Diagnosed by Histology or Cytology, A Multidisciplinary Team Assessment Determined That the Patient Was a Suitable Candidate for Radical Surgical Resection
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.
Manuel V Garnacho-Castaño, PhD principal investigator
Campus docent Sant Joan de Déu-Universitat de Barcelona
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 ingestion in people with Pulmonary Function and Nutrition, Healthy, run by Campus docent Sant Joan de Déu-Universitat de Barcelona at 1 site in Spain.
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 5 inclusion and 2 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 10 Oct 2023. 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 Spain. 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?
Rowing performance: Time trial (time frame: through study completion, an average of 3 weeks). The study lists 7 primary outcomes in all. 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 10 Oct 2023.