Postmenopausal WomenPhase 2NCT03380000
Effect of Beetroot Juice on Blood Pressure Regulation in Post Menopausal Women
A Phase 2 study testing Beetroot juice in people with Postmenopausal Women, run by Penn State University at 1 site in United States.
Trial summary
In this study the investigators will test the hypothesis that acute consumption of inorganic nitrate (supplied in concentrated beetroot juice) reduces artery stiffness and resting blood pressure, and lessens the rise in blood pressure during handgrip exercise in postmenopausal women. Read more about this study
- Who is it for?
- Ages 55 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Women
- What is being tested?
- Beetroot juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2014to Jan 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Resting systolic blood pressure less than or equal to 160 mmHg
- Resting diastolic blood pressure less than or equal to 100 mmHg
Who cannot join
- Overt cardiovascular, metabolic, hematologic, pulmonary, renal, musculoskeletal, and/or neurological disease(s)
- Users of any tobacco and/or nicotine products (smokers, chewing tobacco, nicotine-containing patches/gum, smokeless cigarettes)
- Body mass index greater than 35
- Total cholesterol greater than 239 mg/dl
- LDL cholesterol greater than 159 mg/dl
- Fasting blood triglycerides greater than 199 mg/dl
Show all 14Show fewer
- Fasting blood glucose greater than 109 mg/dl and HbA1c greater than 6.0%
- Individuals currently taking any of the following medications:
- blood pressure lowering medication (e.g., beta blockers, ACE inhibitors, angiotensin antagonists, calcium channel blockers, diuretics)
- lipid-lowering medication (e.g., statins)
- nitrates (e.g. nitroglycerin) for angina
- phosphodiesterase inhibitors (e.g., Viagra)
- anti-inflammatory drugs
- Individuals currently taking hormone replacement therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State University
University Park, Pennsylvania, 16802
About this study
Official title: Acute Blood Pressure-lowering Effects of Beetroot Juice in Postmenopausal Women With and Without Hypertension
In this study the investigators will test the hypothesis that acute consumption of inorganic nitrate (supplied in concentrated beetroot juice) reduces artery stiffness and resting blood pressure, and lessens the rise in blood pressure during handgrip exercise in postmenopausal women. Understanding and improving artery function and blood pressure regulation in women is important because they undergo accelerated arterial stiffening after menopause and have much larger increases in blood pressure when they exercise compared with either premenopausal women or men of similar age.
Read the detailed description
Postmenopausal women have stiff central arteries and exaggerated blood pressure (BP) responses during exercise compared with either premenopausal women or men of similar age. Arterial stiffness and exaggerated BP responses to exercise are prognostic for heart wall thickening, future hypertension, adverse cardiovascular events, and mortality. Previous studies have reported that acute consumption of nitrate-rich beetroot juice can lower resting and exercising BP responses in older adults. However, these studies included both sexes and did not compare the effects of beetroot juice to a nitrate-depleted placebo (a true control). Thus, the potential BP lowering effects of nitrate supplementation per se have not been established in postmenopausal women. The present study examines the acute (single dose) effects of nitrate-rich beetroot juice on resting hemodynamics (peripheral and central BP, arterial wave properties, etc), and physiological responses to handgrip exercise in metabolically healthy post-menopausal women.
- Conditions
- Postmenopausal Women
- Being tested
- Beetroot juice, Beetroot juice placebo
- Keywords
- Dietary nitrate supplementation, Beetroot juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot juiceDrug
Also called Beet-It Organic Shot
This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK).
Beetroot juice placeboDrug
Also called Beet-It Organic placebo
This beverage is identical in look and taste to the Beet-It organic shot, but has the nitrate removed. It is also bottled and supplied by James White Drinks (UK).
| Study group | Role | What they receive |
|---|---|---|
| Nitrate rich beetroot juice | Active comparator | Subjects will consume 140 ml of beetroot juice (Beet-It Organic Shot) approximately 90 min before physiological testing. Receives: Drug: Beetroot juice |
| Nitrate depleted beetroot juice | Placebo comparator | Subjects will consume 140 ml of beetroot juice (Beet-It Organic Placebo) approximately 90 min before physiological testing. Receives: Drug: Beetroot juice placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting Aortic Blood Pressures
Aortic Blood pressures were measured in the arm (cuff) and estimated in the aorta (radial artery tonometry).
Measured: Resting systolic blood pressure at 90 minutes after beetroot juice ingestion
Secondary outcomes (5)
Blood Measures of Nitrate Absorption and Conversion
Venous blood will be withdrawn (venipuncture) for determination of plasma nitrate and nitrite.
Measured: Change from baseline measures of plasma nitrate and nitrite at 90 minutes and at approximately 6 hours
Resting Arterial Stiffness/Wave Properties
Carotid to femoral artery pulse wave velocity will be assessed using arterial tonometry.
Measured: Change from baseline resting pulse wave velocity at 90 minutes after beet root juice ingestion
Handgrip Exercise Blood Pressure Responses (Relative Change From Baseline)
Beat-to-beat blood pressure (finger cuff) will be assessed at rest and during handgrip exercise to volitional fatigue.
Measured: Approximately 180 minutes after ingestion of beetroot juice
Peak Rate of Perceived Exertion Scores During Handgrip Exercise
The Borg Rating of Perceived Exertion Scale (RPE) was used to assess exercise intensity during handgrip exercise. The RPE scale ranges from a minimum of 6 (no exertion at all) to a maximum of 20 (maximal exertion) units on a scale.
Measured: Approximately 90 minutes after ingestion of beetroot juice
Handgrip Exercise Tolerance
Time to fatigue (seconds) was assessed during a progressive blood flow restricted handgrip exercise protocol.
Measured: Approximately 90 minutes after ingestion of beetroot juice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start12 Sep 2014
- Primary completionSep 2019
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postmenopausal WomenStudies of the same condition, open and under way.
- More trials run by Penn State 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David N. Proctor, PhD, Penn State University
- Investigators
- David N Proctor, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380000
- Sponsor's protocol ID
- 00043633
- Status last verified
- Jun 2022
- First submitted
- 10 Dec 2017
- Last updated
- 12 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Blood Pressure-lowering Effects of Beetroot Juice in Postmenopausal Women With and Without Hypertension
- ClinicalTrials.gov ID
- NCT03380000
- Acronym / sponsor ID
- 00043633
- Conditions
- Postmenopausal Women
- Keywords
- Dietary nitrate supplementation, Beetroot juice
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 12 Sep 2014 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 20 Dec 2017 (actual)
- Results
- Posted 23 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study the investigators will test the hypothesis that acute consumption of inorganic nitrate (supplied in concentrated beetroot juice) reduces artery stiffness and resting blood pressure, and lessens the rise in blood pressure during handgrip exercise in postmenopausal women. Understanding and improving artery function and blood pressure regulation in women is important because they undergo accelerated arterial stiffening after menopause and have much larger increases in blood pressure when they exercise compared with either premenopausal women or men of similar age.
Detailed description
Postmenopausal women have stiff central arteries and exaggerated blood pressure (BP) responses during exercise compared with either premenopausal women or men of similar age. Arterial stiffness and exaggerated BP responses to exercise are prognostic for heart wall thickening, future hypertension, adverse cardiovascular events, and mortality. Previous studies have reported that acute consumption of nitrate-rich beetroot juice can lower resting and exercising BP responses in older adults. However, these studies included both sexes and did not compare the effects of beetroot juice to a nitrate-depleted placebo (a true control). Thus, the potential BP lowering effects of nitrate supplementation per se have not been established in postmenopausal women. The present study examines the acute (single dose) effects of nitrate-rich beetroot juice on resting hemodynamics (peripheral and central BP, arterial wave properties, etc), and physiological responses to handgrip exercise in metabolically healthy post-menopausal women.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitrate rich beetroot juice | Active comparator | Drug: Beetroot juiceSubjects will consume 140 ml of beetroot juice (Beet-It Organic Shot) approximately 90 min before physiological testing. |
| Nitrate depleted beetroot juice | Placebo comparator | Drug: Beetroot juice placeboSubjects will consume 140 ml of beetroot juice (Beet-It Organic Placebo) approximately 90 min before physiological testing. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Resting systolic blood pressure less than or equal to 160 mmHg
- Resting diastolic blood pressure less than or equal to 100 mmHg
Key exclusion criteria (14 listed)
- Overt cardiovascular, metabolic, hematologic, pulmonary, renal, musculoskeletal, and/or neurological disease(s)
- Users of any tobacco and/or nicotine products (smokers, chewing tobacco, nicotine-containing patches/gum, smokeless cigarettes)
- Body mass index greater than 35
- Total cholesterol greater than 239 mg/dl
- LDL cholesterol greater than 159 mg/dl
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 juiceAlso: Beet-It Organic ShotThis beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK). | Drug | Nitrate rich beetroot juice |
| Beetroot juice placeboAlso: Beet-It Organic placeboThis beverage is identical in look and taste to the Beet-It organic shot, but has the nitrate removed. It is also bottled and supplied by James White Drinks (UK). | Drug | Nitrate depleted beetroot juice |
Primary outcome
Resting Aortic Blood Pressures
Time frame: Resting systolic blood pressure at 90 minutes after beetroot juice ingestion
Aortic Blood pressures were measured in the arm (cuff) and estimated in the aorta (radial artery tonometry).
5 secondary outcomes
Blood Measures of Nitrate Absorption and Conversion
Time frame: Change from baseline measures of plasma nitrate and nitrite at 90 minutes and at approximately 6 hours
Resting Arterial Stiffness/Wave Properties
Time frame: Change from baseline resting pulse wave velocity at 90 minutes after beet root juice ingestion
Handgrip Exercise Blood Pressure Responses (Relative Change From Baseline)
Time frame: Approximately 180 minutes after ingestion of beetroot juice
Peak Rate of Perceived Exertion Scores During Handgrip Exercise
Time frame: Approximately 90 minutes after ingestion of beetroot juice
Handgrip Exercise Tolerance
Time frame: Approximately 90 minutes after ingestion of beetroot juice
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David N Proctor, PhD principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Beetroot juice in people with Postmenopausal Women, run by Penn State 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 2 inclusion and 14 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 12 Jul 2022. 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. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Resting Aortic Blood Pressures (time frame: Resting systolic blood pressure at 90 minutes after beetroot juice ingestion). 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 12 Jul 2022.