AgingBEE SWEETNCT04370756
Beetroot Supplementation in Women Enjoying Exercise Together
A study testing Beetroot Juice and Exercise Training in people with Aging and Postmenopause, run by Indiana University at 1 site in United States.
Trial summary
This study seeks to determine the feasibility of an exercise training progression with the consumption of beetroot juice prior to exercise in postmenopausal women. Results from this investigation will be used to determine preliminary effect sizes for exercise training only (control) and exercise training + beetroot… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aging, Postmenopause, Obesity
- What is being tested?
- Beetroot Juice and Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2020to 26 May 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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Post-menopausal women (self-report)
- Between the ages of 18-75 years (confirmed by birth date listed on participant's driver license at screening visit)
- Physician's clearance for study participation (required prior to baseline testing)
- English-speaking
- Body mass index between 25.0 to 39.9 kg/m^2 (measured on-site at screening visit)
- Able to ambulate without assistance
Who cannot join
- Unable to provide informed consent
- 18-75 of age (confirmed by birth date listed on participant's driver license at screening visit)
- Body mass index < 25.0 or >39.9 kg/m^2 (measured on-site at screening visit)
- Greater than stage II hypertension (i.e. >159/99 mm Hg)
- Current smoker (self-report)
- Currently pregnant, lactating, or trying to become pregnant (self-report)
Show all 15Show fewer
- Habitually exercise training >= 3 times per week (self-report)
- Significant orthopedic limitations or other contraindications to strenuous exercise
- Live or work >50 miles from Bloomington study site or do not have transportation to the study site
- Anticipate elective surgery during the study period
- Plan to move residence or travel out of the local area during the study period
- History of major metabolic disease (e.g. Type I diabetes, Type II diabetes, thyroid disorders)
- Current use of anti-coagulants (e.g. Coumadin or Warfarin)
- Current use of prescription medications that affect heart rate or blood vessel dilation (e.g. phosphodiesterase-5 inhibitors, proton pump inhibitors, systemic adrenergic blockers, nitrates, calcium channel blockers, hormone replacement therapy) (self-report and confirmed on-site at screening visit)
- Psychological or social characteristic that would interfere with their ability to fully participate in the study (i.e. taking longer than allowed time to complete cognitive assessments)
Trial locations and contacts
1 site in 1 country.
About this study
This study seeks to determine the feasibility of an exercise training progression with the consumption of beetroot juice prior to exercise in postmenopausal women. Results from this investigation will be used to determine preliminary effect sizes for exercise training only (control) and exercise training + beetroot juice (EX+BR) to inform the direction of larger randomized clinical trials on pre-post changes in measures of cardiovascular health and endothelial function.
Read the detailed description
An increasing body of evidence has supported acute benefits of beetroot juice including lowered blood pressure and greater muscle oxygenation during exercise. Thus, consumption of beetroot juice prior to exercise may alter the perceptual difficulty for a given exercise bout -- possibly resulting in an individual exercising at a greater intensity (without the commensurate increase in discomfort). The investigators propose that repeated exposure to a relatively greater exercise stimulus (via beetroot juice) may elicit more robust cardio-metabolic adaptations compared to exercise training alone (i.e., without beetroot juice). Possible findings could inform a larger randomized clinical trial to determine if pre-exercise beetroot juice supplementation is an effective strategy to promote health related benefits.
The investigators will examine the effects of pre-exercise beetroot juice coupled with 8 weeks of supervised exercise training among post-menopausal (75 and younger) women. Qualified individuals will be required to complete an initial screening visit as well as three baseline visits (Visits 1-2). Participants will undergo a series of tests including: dual-energy X-ray absorptiometry scan, bioelectrical impedance analysis, exhaled fraction of nitric oxide, health-related questionnaires, and pulse wave velocity. Participants will also be asked to perform leg muscle function and walking tests. Following the completion of Visits 1-2, participants will attend supervised exercise training sessions 3x/week for 8 weeks. Within 2-6 days from the last exercise training session, participants will repeat the same measurement procedures.
The primary objective involves elements of feasibility (e.g., recruitment, retention, adherence, and adverse event) and to generate preliminary effect sizes for 8 weeks of exercise training for two groups: control and EX+BR. Secondary objectives involve preliminary effect sizes for pre-post changes in distance covered during the 6-minute walk test, changes in endothelial-dependent vasodilation, and biomarkers of cardiovascular health.
- Conditions
- Aging, Postmenopause, Obesity
- Being tested
- Beetroot Juice, Exercise Training
- Keywords
- Beetroot juice, Postmenopause, Exercise training, Endothelial function
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot JuiceDietary supplement
Participants randomly assigned to the EX + BR group will consume 140 mL beetroot juice containing approximately 12 mmol of nitrate 3 hours prior to the supervised exercise training component.
Exercise TrainingOther
Participants will perform 8 weeks of supervised exercise training at a frequency of 3x per week.
| Study group | Role | What they receive |
|---|---|---|
| Ex only | Active comparator | Participants will perform 8 weeks of supervised exercise training (EX). Receives: Other: Exercise Training |
| EX + BR | Experimental | Participants will perform 8 weeks of supervised exercise training (EX) plus pre-exercise consumption of beetroot juice (BR). Receives: Dietary Supplement: Beetroot Juice; Other: Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
The number of eligible participants randomized per months of recruitment time.
Measured: 24 months
Retention rate
The number of randomized participants who complete at least 17 (out of 24 possible) exercise training sessions.
Measured: 8 weeks
Adherence to exercise training intervention
The percent of exercise sessions attended out of the 24 possible sessions.
Measured: 8 weeks
Adherence to dietary nitrate intervention
Breath analysis of fractional exhaled nitric oxide concentrations.
Measured: 8 weeks
Perceived difficulty of training sessions
Participants will report the perceived exertion at the end of exercise sessions using the Borg category ratio-10 scale that ranges from 0 "no exertion" to 10 "maximal exertion".
Measured: 8 weeks
Secondary outcomes (2)
Distance covered during a six-minute walk test
Participants will be asked to walk as far as possible at a preferred speed for six minutes according to ATS standards. Distance covered will be measured in meters.
Measured: Baseline, post-intervention
Soluble endothelial microparticles
Blood samples will be analyzed for adhesion molecules (sICAM-1, sVCAM-1, sE-selectin).
Measured: Baseline, post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start30 Jan 2020
- Primary completion26 May 2023
- Study completion26 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be enrolled in small (n = 4) cohorts or "waves" to facilitate social support and adherence to the supervised exercise training sessions. We anticipate having 9 waves to successfully reach our target n. This assumes that each wave will have 4 participants, hence, 4 participants x 9 waves = 36 total participants. Subsequently, participants will be randomly selected to: 1) control (EX only) or 2) EX + Beetroot Juice.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- IU Health University Hospital, Indiana CTSI Clinical Research Center, Bloomington Crossfit
- Responsible party
- Principal investigator, Stephen J. Carter, Ph.D., Indiana University
- Investigators
- Stephen J Carter, Ph.D., Principal investigator, Indiana University, Bloomington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04370756
- Sponsor's protocol ID
- 1907026303
- Acronym
- BEE SWEET
- Status last verified
- Feb 2024
- First submitted
- 18 Apr 2020
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IDP sharing plan
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beetroot Supplementation in Women Enjoying Exercise Together
- ClinicalTrials.gov ID
- NCT04370756
- Acronym / sponsor ID
- BEE SWEET / 1907026303
- Conditions
- Aging, Postmenopause, Obesity
- Keywords
- Beetroot juice, Postmenopause, Exercise training, Endothelial function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- IU Health University Hospital, Indiana CTSI Clinical Research Center, Bloomington Crossfit
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 26 May 2023 (actual)
- Study completion
- 26 May 2023 (actual)
- First posted
- 1 May 2020 (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 seeks to determine the feasibility of an exercise training progression with the consumption of beetroot juice prior to exercise in postmenopausal women. Results from this investigation will be used to determine preliminary effect sizes for exercise training only (control) and exercise training + beetroot juice (EX+BR) to inform the direction of larger randomized clinical trials on pre-post changes in measures of cardiovascular health and endothelial function.
Detailed description
An increasing body of evidence has supported acute benefits of beetroot juice including lowered blood pressure and greater muscle oxygenation during exercise. Thus, consumption of beetroot juice prior to exercise may alter the perceptual difficulty for a given exercise bout -- possibly resulting in an individual exercising at a greater intensity (without the commensurate increase in discomfort). The investigators propose that repeated exposure to a relatively greater exercise stimulus (via beetroot juice) may elicit more robust cardio-metabolic adaptations compared to exercise training alone (i.e., without beetroot juice). Possible findings could inform a larger randomized clinical trial to determine if pre-exercise beetroot juice supplementation is an effective strategy to promote health related benefits.
The investigators will examine the effects of pre-exercise beetroot juice coupled with 8 weeks of supervised exercise training among post-menopausal (75 and younger) women. Qualified individuals will be required to complete an initial screening visit as well as three baseline visits (Visits 1-2). Participants will undergo a series of tests including: dual-energy X-ray absorptiometry scan, bioelectrical impedance analysis, exhaled fraction of nitric oxide, health-related questionnaires, and pulse wave velocity. Participants will also be asked to perform leg muscle function and walking tests. Following the completion of Visits 1-2, participants will attend supervised exercise training sessions 3x/week for 8 weeks. Within 2-6 days from the last exercise training session, participants will repeat the same measurement procedures.
The primary objective involves elements of feasibility (e.g., recruitment, retention, adherence, and adverse event) and to generate preliminary effect sizes for 8 weeks of exercise training for two groups: control and EX+BR. Secondary objectives involve preliminary effect sizes for pre-post changes in distance covered during the 6-minute walk test, changes in endothelial-dependent vasodilation, and biomarkers of cardiovascular health.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be enrolled in small (n = 4) cohorts or "waves" to facilitate social support and adherence to the supervised exercise training sessions. We anticipate having 9 waves to successfully reach our target n. This assumes that each wave will have 4 participants, hence, 4 participants x 9 waves = 36 total participants. Subsequently, participants will be randomly selected to: 1) control (EX only) or 2) EX + Beetroot Juice.
| Arm | Type | Receives |
|---|---|---|
| Ex only | Active comparator | Other: Exercise TrainingParticipants will perform 8 weeks of supervised exercise training (EX). |
| EX + BR | Experimental | Dietary Supplement: Beetroot Juice, Other: Exercise TrainingParticipants will perform 8 weeks of supervised exercise training (EX) plus pre-exercise consumption of beetroot juice (BR). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Post-menopausal women (self-report)
- Between the ages of 18-75 years (confirmed by birth date listed on participant's driver license at screening visit)
- Physician's clearance for study participation (required prior to baseline testing)
- English-speaking
- Body mass index between 25.0 to 39.9 kg/m^2 (measured on-site at screening visit)
Key exclusion criteria (15 listed)
- Unable to provide informed consent
- 18-75 of age (confirmed by birth date listed on participant's driver license at screening visit)
- Body mass index < 25.0 or >39.9 kg/m^2 (measured on-site at screening visit)
- Greater than stage II hypertension (i.e. >159/99 mm Hg)
- Current smoker (self-report)
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 JuiceParticipants randomly assigned to the EX + BR group will consume 140 mL beetroot juice containing approximately 12 mmol of nitrate 3 hours prior to the supervised exercise training component. | Dietary supplement | EX + BR |
| Exercise TrainingParticipants will perform 8 weeks of supervised exercise training at a frequency of 3x per week. | Other | EX + BR, Ex only |
Primary outcome
Recruitment rate
Time frame: 24 months
The number of eligible participants randomized per months of recruitment time.
Retention rate
Time frame: 8 weeks
The number of randomized participants who complete at least 17 (out of 24 possible) exercise training sessions.
Adherence to exercise training intervention
Time frame: 8 weeks
The percent of exercise sessions attended out of the 24 possible sessions.
Adherence to dietary nitrate intervention
Time frame: 8 weeks
Breath analysis of fractional exhaled nitric oxide concentrations.
Perceived difficulty of training sessions
Time frame: 8 weeks
Participants will report the perceived exertion at the end of exercise sessions using the Borg category ratio-10 scale that ranges from 0 "no exertion" to 10 "maximal exertion".
2 secondary outcomes
Distance covered during a six-minute walk test
Time frame: Baseline, post-intervention
Soluble endothelial microparticles
Time frame: Baseline, post-intervention
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 21 Feb 2024.
- Individual participant dataSharing planned: No. No IDP sharing plan
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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.
Stephen J Carter, Ph.D. principal investigator
Indiana University, Bloomington
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 and Exercise Training in people with Aging and Postmenopause, run by Indiana University 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 6 inclusion and 15 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 21 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?
Recruitment rate (time frame: 24 months). The study lists 5 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 21 Feb 2024.