Dietary HabitsNCT06045845
Effects of Beet Juice and Diet in Female Rowers
A study testing Beet Juice in people with Dietary Habits and Nitrates, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of nitrate-rich beetroot juice supplementation on exercise performance in female rowers when accounting for habitual vegetable nitrate consumption. 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
- Dietary Habits, Nitrates, Exercise
- What is being tested?
- Beet Juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Athletes currently on the university's rowing team
Who cannot join
- Injuries or medical conditions that prevent participation in their team's rowing training program
- Diagnosis of stage 2 iron deficiency
- Unable to consume beet juice for any reason
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Rowing Boathouse
Lawrence, Kansas, 66044
About this study
Official title: The Effects of Beetroot Supplementation and Habitual Dietary Nitrate Intake on Exercise Performance in Collegiate Female Rowing Athletes
The purpose of this study is to determine the effects of nitrate-rich beetroot juice supplementation on exercise performance in female rowers when accounting for habitual vegetable nitrate consumption.
Read the detailed description
The objective is to use a stratified block randomization, double-blind crossover trial to test rowing ergometer exercise performance after drinking a beetroot juice supplement and compare it to the same test after consuming a placebo (a nitrate-free version of the beetroot juice supplement) in a convenience sample of athletes from a single Division 1-A collegiate women's rowing team.
Before testing, the participants' habitual vegetable nitrate consumption will be assessed from their report of foods consumed in the past 24 hours. Estimates of dietary nitrate intake will be calculated from the quantity of vegetables consumed and used to determine whether dietary nitrate intake influences the efficacy of the beetroot juice supplement.
- Conditions
- Dietary Habits, Nitrates, Exercise
- Being tested
- Beet Juice, Placebo
- Keywords
- dietary nitrate, beetroot juice, sex differences, exercise, performance, muscle
- Medical subject headings
- Feeding Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beet JuiceDietary supplement
70 milliliter (70mL) standard Beet Juice (Beet It Sport Shot) consumed 2.5 hours before exercise test
PlaceboDietary supplement
70mL placebo Beet Juice (Beet It Sport Shot with nitrate removed) consumed 2.5 hours before exercise test
| Study group | Role | What they receive |
|---|---|---|
| Standard Beet Juice First | Experimental | First Test: Beet Juice / Second Test: Placebo Receives: Dietary Supplement: Beet Juice; Dietary Supplement: Placebo |
| Placebo Beet Juice First | Experimental | First Test: Placebo / Second Test: Beet Juice Receives: Dietary Supplement: Beet Juice; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rowing Test Time
Time (seconds) to complete 500-meter rowing time trial tests.
Measured: Recorded immediately upon completion of each of the 4 500-meter intervals during rowing time trial tests on day 7 and day 14.
Rowing Test Perceived Exertion
Rating of perceived exertion reported by participant during rowing time trial tests. The Borg Scale is used, in which participants choose a number between 6 ("Rest") and 20 ("Maximal Effort") to indicate their perceived exertion at the completion of each 500-meter segment.
Measured: Recorded immediately upon completion of each of the 4 500-meter intervals during rowing time trial tests on day 7 and day 14.
Rowing Test Peak Heart Rate
Maximum heart rate (beats per minute) during 500-meter rowing time trial tests. The Maximum is the single highest heart rate recorded during that 500-meter interval.
Measured: Recorded during each of the 4 500-meter intervals during rowing time trial tests on day 7 and day 14.
Rowing Test Average Heart Rate
Mean heart rate (beets per minute) during 500-meter rowing time trial tests.
Measured: Recorded during each of the 4 500-meter intervals during rowing time trial tests on day 7 and day 14.
Rowing Test Peak Power Output
Maximum power (watts) during 500-meter rowing time trial tests
Measured: Recorded during each of the 4 500-meter intervals during rowing time trial tests on day 7 and day 14.
Rowing Test Average Power Output
Mean power (watts) during 500-meter rowing time trial tests
Measured: Recorded during each of the 4 500-meter intervals during rowing time trial tests on day 7 and day 14.
Dietary Nitrate Habitual Consumption Amount
Mean vegetable nitrate consumption (mg/day) from two different self-administered 24-hour dietary recalls (ASA24).
Measured: Collected after each rowing time trial test for the preceding 24-hour period (day 6 and day 13). Means determined in post-testing analysis.
Dietary Nitrate Habitual Consumption Category
Categorization of Dietary Nitrate Habitual Consumption Amount. The median of all participants' Amounts will be determined to categorize each participant as "high" (above median) or "low (below median).
Measured: Collected after each rowing time trial test for the preceding 24-hour period (day 6 and day 13). Median and categories determined in post-testing analysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start3 Oct 2023
- Primary completion17 Nov 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 Dietary HabitsStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Provost, University of Kansas Medical Center
- Investigators
- Jessica A Provost, MS, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045845
- Sponsor's protocol ID
- STUDY00150492
- Status last verified
- Jan 2024
- First submitted
- 13 Sep 2023
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon completion of the testing protocol, all data analysis will be conducted using only using the de-identified participant identification numbers. There is no plan to share individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Beetroot Supplementation and Habitual Dietary Nitrate Intake on Exercise Performance in Collegiate Female Rowing Athletes
- ClinicalTrials.gov ID
- NCT06045845
- Acronym / sponsor ID
- STUDY00150492
- Conditions
- Dietary Habits, Nitrates, Exercise
- Keywords
- dietary nitrate, beetroot juice, sex differences, exercise, performance, muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 21 Sep 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.
The purpose of this study is to determine the effects of nitrate-rich beetroot juice supplementation on exercise performance in female rowers when accounting for habitual vegetable nitrate consumption.
Detailed description
The objective is to use a stratified block randomization, double-blind crossover trial to test rowing ergometer exercise performance after drinking a beetroot juice supplement and compare it to the same test after consuming a placebo (a nitrate-free version of the beetroot juice supplement) in a convenience sample of athletes from a single Division 1-A collegiate women's rowing team.
Before testing, the participants' habitual vegetable nitrate consumption will be assessed from their report of foods consumed in the past 24 hours. Estimates of dietary nitrate intake will be calculated from the quantity of vegetables consumed and used to determine whether dietary nitrate intake influences the efficacy of the beetroot juice supplement.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Beet Juice First | Experimental | Dietary Supplement: Beet Juice, Dietary Supplement: PlaceboFirst Test: Beet Juice / Second Test: Placebo |
| Placebo Beet Juice First | Experimental | Dietary Supplement: Beet Juice, Dietary Supplement: PlaceboFirst Test: Placebo / Second Test: Beet Juice |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy
- Athletes currently on the university's rowing team
Key exclusion criteria (3 listed)
- Injuries or medical conditions that prevent participation in their team's rowing training program
- Diagnosis of stage 2 iron deficiency
- Unable to consume beet juice for any reason
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 |
|---|---|---|
| Beet Juice70 milliliter (70mL) standard Beet Juice (Beet It Sport Shot) consumed 2.5 hours before exercise test | Dietary supplement | Placebo Beet Juice First, Standard Beet Juice First |
| Placebo70mL placebo Beet Juice (Beet It Sport Shot with nitrate removed) consumed 2.5 hours before exercise test | Dietary supplement | Placebo Beet Juice First, Standard Beet Juice First |
Primary outcome
Rowing Test Time
Time frame: Recorded immediately upon completion of each of the 4 500-meter intervals during rowing time trial tests on day 7 and day 14.
Time (seconds) to complete 500-meter rowing time trial tests.
Rowing Test Perceived Exertion
Time frame: Recorded immediately upon completion of each of the 4 500-meter intervals during rowing time trial tests on day 7 and day 14.
Rating of perceived exertion reported by participant during rowing time trial tests. The Borg Scale is used, in which participants choose a number between 6 ("Rest") and 20 ("Maximal Effort") to indicate their perceived exertion at the completion of each 500-meter segment.
Rowing Test Peak Heart Rate
Time frame: Recorded during each of the 4 500-meter intervals during rowing time trial tests on day 7 and day 14.
Maximum heart rate (beats per minute) during 500-meter rowing time trial tests. The Maximum is the single highest heart rate recorded during that 500-meter interval.
Rowing Test Average Heart Rate
Time frame: Recorded during each of the 4 500-meter intervals during rowing time trial tests on day 7 and day 14.
Mean heart rate (beets per minute) during 500-meter rowing time trial tests.
Rowing Test Peak Power Output
Time frame: Recorded during each of the 4 500-meter intervals during rowing time trial tests on day 7 and day 14.
Maximum power (watts) during 500-meter rowing time trial tests
Rowing Test Average Power Output
Time frame: Recorded during each of the 4 500-meter intervals during rowing time trial tests on day 7 and day 14.
Mean power (watts) during 500-meter rowing time trial tests
Dietary Nitrate Habitual Consumption Amount
Time frame: Collected after each rowing time trial test for the preceding 24-hour period (day 6 and day 13). Means determined in post-testing analysis.
Mean vegetable nitrate consumption (mg/day) from two different self-administered 24-hour dietary recalls (ASA24).
Dietary Nitrate Habitual Consumption Category
Time frame: Collected after each rowing time trial test for the preceding 24-hour period (day 6 and day 13). Median and categories determined in post-testing analysis.
Categorization of Dietary Nitrate Habitual Consumption Amount. The median of all participants' Amounts will be determined to categorize each participant as "high" (above median) or "low (below median).
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 2 Feb 2024.
- Individual participant dataSharing planned: No. Upon completion of the testing protocol, all data analysis will be conducted using only using the de-identified participant identification numbers. There is no plan to share individual participant data with other researchers.
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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.
Jessica A Provost, MS principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beet Juice in people with Dietary Habits and Nitrates, run by University of Kansas Medical Center at 1 site in United States.
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 2 Feb 2024. 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 United States. 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. 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 Test Time (time frame: Recorded immediately upon completion of each of the 4 500-meter intervals during rowing time trial tests on day 7 and day 14.). The study lists 8 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 2 Feb 2024.