Postmenopausal WomenPhase 2NCT03644472
Postmenopausal Women and Their Endothelium
A Phase 2 study testing nitrate rich beetroot juice and nitrate depleted beetroot juice in people with Postmenopausal Women, run by Penn State University at 1 site in United States.
Trial summary
The purpose of this study is to test the effects of a one time dose and 7-days of inorganic nitrate (supplied in the form of beetroot juice) on blood vessel function and resting blood pressure in healthy, postmenopausal women. Read more about this study
- Who is it for?
- Ages Up to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Women
- What is being tested?
- nitrate rich beetroot juice and nitrate depleted beetroot juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2018to 20 Feb 2023
- Phase
- Phase 2
- 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 Up to 70 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Early post-menopausal women who are within 1-6 years following their final menstrual cycle
- Late post-menopausal women who are beyond 6 years following their final menstrual cycle
Who cannot join
- Individuals with any 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)
- Individuals with a BMI > 35
- Individuals with resting blood pressure > or = 130/80 mm Hg
- Individuals with high blood lipids (total cholesterol > or = 240 mg/dl, LDL > or = 160 mg/dl, triglycerides > or = 200 mg/dl).
- Postmenopausal women with hyperglycemia (fasting glucose > or = 110 mg/dl and HbA1c >6.0%).
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- Individuals 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 taking hormone 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: Postmenopausal Women and Their Endothelium: Is Dietary Nitrate Supplementation Protective
The purpose of this study is to test the effects of a one time dose and 7-days of inorganic nitrate (supplied in the form of beetroot juice) on blood vessel function and resting blood pressure in healthy, postmenopausal women. Participants will drink beetroot juice and a placebo juice on separate visits where blood pressure and blood vessel function will be measured.
Read the detailed description
Cardiovascular disease is the leading cause of death in the United States. Due to the loss of estrogen, women experience a unique accelerated rise in cardiovascular disease risk factors following menopause. Postmenopausal women represent a population at heightened risk for cardiovascular disease development. Function of the endothelium has been shown to decline across the menopause transition, resulting in less production of nitric oxide. As such the investigators are investigating a potential therapeutic strategy in women have recently undergone menopause to boost nitric oxide availability.
- Conditions
- Postmenopausal Women
- Being tested
- nitrate rich beetroot juice, nitrate depleted beetroot juice
- 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.
nitrate rich 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).
nitrate depleted beetroot juiceDrug
Also called Beet-it Organic Shot 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: nitrate rich 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: nitrate depleted beetroot juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macro-vascular reactivity
Using near-infrared spectroscopy, a probe placed on the forearm muscle will be used to measure the tissue saturation index re-perfusion slope following 5 minutes of forearm cuff occlusion.
Measured: These measurements will take place before and after a ischemia-reperfusion injury (20 minutes inflation, 20 minutes deflation) induced in the upper arm to assess change in macro-vascular reactivity
Micro-vascular reactivity
Using near-infrared spectroscopy, a probe placed on the forearm muscle will be used to measure area under the curve for tissue saturation index re-perfusion following 5 minutes of forearm cuff occlusion.
Measured: These measurements will take place before and after a ischemia-reperfusion injury (20 minutes inflation, 20 minutes deflation) induced in the upper arm to assess change in micro-vascular reactivity
Secondary outcomes (4)
Resting blood pressures
Resting systolic blood pressures will be measured in the arm (cuff) and estimated in the aorta (radial artery tonometry).
Measured: Change from baseline resting blood pressure and at 90 minutes after beet root juice ingestion
Recovery of micro-vascular function and brachial artery flow mediated dilation
Micro-vascular and brachial artery flow-mediated dilation, as described above, will be reassessed 30 minutes following ischemia-reperfusion injury to determine recovery of vessel function.
Measured: Change in these measures from immediately after ischemia-reperfusion injury to 30 minutes following
Brachial artery flow-mediated dilation
Using doppler ultrasound the brachial artery diameter will be measured before and after 5 minutes of forearm cuff occlusion
Measured: These measurements will take place before and after a ischemia-reperfusion injury (20 minutes inflation, 20 minutes deflation) induced in the upper arm to assess change in brachial artery flow-mediated dilation
Brachial ankle pulse wave velocity and ankle-brachial index
Using the VP-Colin 2000 brachial ankle pulse wave velocity and ankle brachial index will be measured before and after supplementation
Measured: These measurements will take place before (day 1) and 24 hours after (day 8) 7 days of supplementation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start7 Nov 2018
- Primary completion20 Feb 2023
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal WomenStudies 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 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
- NCT03644472
- Sponsor's protocol ID
- 00010017
- Status last verified
- Feb 2023
- First submitted
- 20 Aug 2018
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Delgado Spicuzza JM, Gosalia J, Zhong L, Bondonno C, Petersen KS, De Souza MJ, Alipour E, Kim-Shapiro DB, Somani YB, Proctor DN. Seven-day dietary nitrate supplementation clinically significantly improves basal macrovascular function in postmenopausal women: a randomized, placebo-controlled, double-blind, crossover clinical trial. Front Nutr. 2024 Jun 10;11:1359671. doi: 10.3389/fnut.2024.1359671. eCollection 2024.
PubMed 38915856
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postmenopausal Women and Their Endothelium: Is Dietary Nitrate Supplementation Protective
- ClinicalTrials.gov ID
- NCT03644472
- Acronym / sponsor ID
- 00010017
- Conditions
- Postmenopausal Women
- Keywords
- dietary nitrate supplementation, beetroot juice
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 23 Aug 2018 (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 test the effects of a one time dose and 7-days of inorganic nitrate (supplied in the form of beetroot juice) on blood vessel function and resting blood pressure in healthy, postmenopausal women. Participants will drink beetroot juice and a placebo juice on separate visits where blood pressure and blood vessel function will be measured.
Detailed description
Cardiovascular disease is the leading cause of death in the United States. Due to the loss of estrogen, women experience a unique accelerated rise in cardiovascular disease risk factors following menopause. Postmenopausal women represent a population at heightened risk for cardiovascular disease development. Function of the endothelium has been shown to decline across the menopause transition, resulting in less production of nitric oxide. As such the investigators are investigating a potential therapeutic strategy in women have recently undergone menopause to boost nitric oxide availability.
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: nitrate rich 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: nitrate depleted beetroot juiceSubjects will consume 140 ml of beetroot juice (Beet-It Organic Placebo) approximately 90 min before physiological testing. |
Who may qualify
- Ages
- Up to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Early post-menopausal women who are within 1-6 years following their final menstrual cycle
- Late post-menopausal women who are beyond 6 years following their final menstrual cycle
Key exclusion criteria (13 listed)
- Individuals with any 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)
- Individuals with a BMI > 35
- Individuals with resting blood pressure > or = 130/80 mm Hg
- Individuals with high blood lipids (total cholesterol > or = 240 mg/dl, LDL > or = 160 mg/dl, triglycerides > or = 200 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 |
|---|---|---|
| nitrate rich 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 |
| nitrate depleted beetroot juiceAlso: Beet-it Organic Shot 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
Macro-vascular reactivity
Time frame: These measurements will take place before and after a ischemia-reperfusion injury (20 minutes inflation, 20 minutes deflation) induced in the upper arm to assess change in macro-vascular reactivity
Using near-infrared spectroscopy, a probe placed on the forearm muscle will be used to measure the tissue saturation index re-perfusion slope following 5 minutes of forearm cuff occlusion.
Micro-vascular reactivity
Time frame: These measurements will take place before and after a ischemia-reperfusion injury (20 minutes inflation, 20 minutes deflation) induced in the upper arm to assess change in micro-vascular reactivity
Using near-infrared spectroscopy, a probe placed on the forearm muscle will be used to measure area under the curve for tissue saturation index re-perfusion following 5 minutes of forearm cuff occlusion.
4 secondary outcomes
Resting blood pressures
Time frame: Change from baseline resting blood pressure and at 90 minutes after beet root juice ingestion
Recovery of micro-vascular function and brachial artery flow mediated dilation
Time frame: Change in these measures from immediately after ischemia-reperfusion injury to 30 minutes following
Brachial artery flow-mediated dilation
Time frame: These measurements will take place before and after a ischemia-reperfusion injury (20 minutes inflation, 20 minutes deflation) induced in the upper arm to assess change in brachial artery flow-mediated dilation
Brachial ankle pulse wave velocity and ankle-brachial index
Time frame: These measurements will take place before (day 1) and 24 hours after (day 8) 7 days of supplementation.
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 27 Feb 2023.
- Derived from this study: PubMed 38915856Delgado Spicuzza JM, Gosalia J, Zhong L, Bondonno C, Petersen KS, De Souza MJ, Alipour E, Kim-Shapiro DB, Somani YB, Proctor DN. Seven-day dietary nitrate supplementation clinically significantly improves basal macrovascular function in postmenopausal women: a randomized, placebo-controlled, double-blind, crossover clinical trial. Front Nutr. 2024 Jun 10;11:1359671. doi: 10.3389/fnut.2024.1359671. eCollection 2024.
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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 nitrate rich beetroot juice and nitrate depleted 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 13 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 27 Feb 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 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?
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?
Macro-vascular reactivity (time frame: These measurements will take place before and after a ischemia-reperfusion injury (20 minutes inflation, 20 minutes deflation) induced in the upper arm to assess change in macro-vascular reactivity). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03644472, which also lists 1 linked publication.
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 27 Feb 2023.