Muscular EnduranceNCT04987619
Effect of Beetroot Juice Supplements on Lower-limb Strength in Females
A study testing Beetroot juice and Capri-Sun in people with Muscular Endurance, run by Maimónides Biomedical Research Institute of Córdoba at 6 sites in 2 countries.
Trial summary
This study aims to evaluate the effects of beetroot juice supplements on lower-limb strength and muscular endurance in physically active women, due to the presence of NO3- in beetroot juice. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Muscular Endurance
- What is being tested?
- Beetroot juice and Capri-Sun
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 5 Jul 2021to 29 Aug 2021
- 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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Physically active females with 18-30 years of age
- More than 6 months on RT training programs
- Be familiarized with back squat, leg press and leg extension exercises
- Not consuming any type of nutritional supplement or anabolic substances in the previous three months or during the study
- Not suffering from a musculoskeletal injury that could interfere with the exercise protocol during the investigation
Who cannot join
- None
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Spain5 sites
Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba
Córdoba, 14004
Metabolism and Investigation Unit, Maimonides Biomedical Research Institute of Cordoba (IMIBIC),Reina Sofia University Hospital, University of Cordoba
Córdoba, 14004
Department of Food Science and Technology, Rabanales University Campus, University of Cordoba
Córdoba, 14071
Department of Nursing Pharmacology and Physiotherapy, Faculty of Medicine and Nursing, University of Córdoba
Córdoba, 14071
Departamento de Motricidad Humana y Rendimiento Deportivo, Universidad de Sevilla
Seville, 41013
Brazil1 site
Studies Research Group in Neuromuscular Responses (GEPREN), University of Lavras
Lavras, 37200-000
About this study
Official title: Acute Effects of Beetroot Juice Supplements on Lower-limb Strength and Muscular Endurance in Physically Active Women: Double-blind Crossover Randomized Trial
This study aims to evaluate the effects of beetroot juice supplements on lower-limb strength and muscular endurance in physically active women, due to the presence of NO3- in beetroot juice.
Read the detailed description
Beetroot juice (BJR) is used as an ergogenic aid, but no study has analyzed its' effects on explosive force production in physically active women. It has been proposed that females could blunt reduction of NO2- to NO based on a higher oxidative skeletal muscle phenotype than males. However, it has been observed a higher increase on plasma NO2- levels after supplementation compared to and a greater enhancement on muscle contractile function.
Based on the absence of any study that has analyzed the effect of NO3- supplements on jump ability and power production on weightlifting on female population; the purpose of this study will be to investigate the possible ergogenic effect of BJR on physically active women on explosive force production and muscular endurance in a lower-limb body weightlifting protocol, due to the presence of NO3- in BJR and its effects.
- Conditions
- Muscular Endurance
- Being tested
- Beetroot juice, Capri-Sun
- Keywords
- Explosive force production, Beetroot juice, Beetroot, muscular endurance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot juiceDietary supplement
Subjects will drink juice 120 minutes before each visit
Capri-SunOther
70 mL of blackcurrant beverage, which is depleted of NO3- will be taken 120 min before each visit.
| Study group | Role | What they receive |
|---|---|---|
| BJR | Experimental | 70 mL of beetroot juice (BEET It Sport®; James White Drinks Ltd., Ipswich, UK) Receives: Dietary Supplement: Beetroot juice |
| PLA | Placebo comparator | 70 mL of blackcurrant beverage Capri-Sun. Receives: Other: Capri-Sun |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of height reached in jump
Evaluated through CMJ (Counter movement jump) test with a recovery period of 45 seconds between jumps.
Measured: Week 1, 2 and 3.
Secondary outcomes (4)
Movement velocity
Evaluated at 50% and 75% repetition maximum (RM)
Measured: Visit 1 (week 1), 2 (week 2) and 3 (week 3).
Power on back squat
Evaluated at 50% and 75% repetition maximum (RM)
Measured: Visit 1 (week 1), 2 (week 2) and 3 (week 3).
Muscular endurance test
The test consists of three exercises: back squat, leg press and leg extension. Three series will be performed until concentric failure at 75% RM, three minutes of rest between each series.
Measured: Visit 1 (week 1), 2 (week 2) and 3 (week 3).
Rating of perceived exertion (RPE).
Immediately at the end of the muscular endurance test, participants will be instructed to report their RPE using a scale 1-10 (worse to better outcome).
Measured: Visit 1 (week 1), 2 (week 2) and 3 (week 3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start5 Jul 2021
- Primary completion29 Aug 2021
- Study completion29 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscular EnduranceStudies 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
- The experimental procedure will consist of three visits, separate from each other by one week, to achieve the total elimination of any effects caused by BJR as well as the optimal recovery of the participants.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose Manuel Jurado Castro, Principal investigator, Hospital General Universitario Reina Sofía de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987619
- Sponsor's protocol ID
- BEETROOT JUICE
- Status last verified
- Jul 2021
- First submitted
- 20 Jul 2021
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared after the study concludes and results are published
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Beetroot Juice Supplements on Lower-limb Strength and Muscular Endurance in Physically Active Women: Double-blind Crossover Randomized Trial
- ClinicalTrials.gov ID
- NCT04987619
- Acronym / sponsor ID
- BEETROOT JUICE
- Conditions
- Muscular Endurance
- Keywords
- Explosive force production, Beetroot juice, Beetroot, muscular endurance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 29 Aug 2021 (actual)
- Study completion
- 29 Aug 2021 (actual)
- First posted
- 3 Aug 2021 (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 aims to evaluate the effects of beetroot juice supplements on lower-limb strength and muscular endurance in physically active women, due to the presence of NO3- in beetroot juice.
Detailed description
Beetroot juice (BJR) is used as an ergogenic aid, but no study has analyzed its' effects on explosive force production in physically active women. It has been proposed that females could blunt reduction of NO2- to NO based on a higher oxidative skeletal muscle phenotype than males. However, it has been observed a higher increase on plasma NO2- levels after supplementation compared to and a greater enhancement on muscle contractile function.
Based on the absence of any study that has analyzed the effect of NO3- supplements on jump ability and power production on weightlifting on female population; the purpose of this study will be to investigate the possible ergogenic effect of BJR on physically active women on explosive force production and muscular endurance in a lower-limb body weightlifting protocol, due to the presence of NO3- in BJR and its effects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The experimental procedure will consist of three visits, separate from each other by one week, to achieve the total elimination of any effects caused by BJR as well as the optimal recovery of the participants.
| Arm | Type | Receives |
|---|---|---|
| BJR | Experimental | Dietary Supplement: Beetroot juice70 mL of beetroot juice (BEET It Sport®; James White Drinks Ltd., Ipswich, UK) |
| PLA | Placebo comparator | Other: Capri-Sun70 mL of blackcurrant beverage Capri-Sun. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Physically active females with 18-30 years of age
- More than 6 months on RT training programs
- Be familiarized with back squat, leg press and leg extension exercises
- Not consuming any type of nutritional supplement or anabolic substances in the previous three months or during the study
- Not suffering from a musculoskeletal injury that could interfere with the exercise protocol during the investigation
Key exclusion criteria (1 listed)
- None
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 juiceSubjects will drink juice 120 minutes before each visit | Dietary supplement | BJR |
| Capri-Sun70 mL of blackcurrant beverage, which is depleted of NO3- will be taken 120 min before each visit. | Other | PLA |
Primary outcome
Change of height reached in jump
Time frame: Week 1, 2 and 3.
Evaluated through CMJ (Counter movement jump) test with a recovery period of 45 seconds between jumps.
4 secondary outcomes
Movement velocity
Time frame: Visit 1 (week 1), 2 (week 2) and 3 (week 3).
Power on back squat
Time frame: Visit 1 (week 1), 2 (week 2) and 3 (week 3).
Muscular endurance test
Time frame: Visit 1 (week 1), 2 (week 2) and 3 (week 3).
Rating of perceived exertion (RPE).
Time frame: Visit 1 (week 1), 2 (week 2) and 3 (week 3).
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 31 Aug 2021.
- Individual participant dataSharing planned: Yes. Data will be shared after the study concludes and results are published
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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.
Jose Manuel Jurado Castro principal investigator
Hospital General Universitario Reina Sofía de Murcia
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beetroot juice and Capri-Sun in people with Muscular Endurance, run by Maimónides Biomedical Research Institute of Córdoba at 6 sites in 2 countries.
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 1 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 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain, 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?
Change of height reached in jump (time frame: Week 1, 2 and 3.). 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 31 Aug 2021.