Post MenopausalNCT05810974
The Impact of Inorganic Nitrate-rich Beetroot Juice on Microvascular Blood Flow and Cognitive Function
A study testing Concentrated beetroot juice, Nitrate depleted beetroot juice + potassium nitrate (KNO3) and Nitrate depleted beetroot juice in people with Post Menopausal, run by University of Reading at 1 site in United Kingdom.
Trial summary
Cardiovascular disease (CVD) is one of the leading causes of mortality worldwide. Inorganic nitrate found in beetroot and green leafy vegetables has been demonstrated to reduce cardiovascular disease risk factors including reducing blood pressure and the stiffness of blood vessels by increasing levels of a compound… Read more about this study
- Who is it for?
- Ages 45 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Menopausal
- What is being tested?
- Concentrated beetroot juice, Nitrate depleted beetroot juice + potassium nitrate (KNO3) and Nitrate depleted beetroot juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Mar 2023to 7 Aug 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 45 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Apparently healthy post-menopausal women (age over 45)
- Able to understand information sheet and willing to comply with the study protocol and able to give informed consent
- Not having menstrual period for 12 months
Who cannot join
- Blood pressure <90/60 or > 140/90 mmHg
- Medical history of myocardial infarction, angina, thrombosis, stroke, cancer, high cholesterol, liver, renal, respiratory or bowel diseases or diabetes or other endocrine disorder
- BMI>30
- Any tobacco and/or nicotine users (or quit within the last 6 months)
- Current use of antihypertensive medication
- Alcohol intake > 14 units/week
Show all 10Show fewer
- Vigorous exercise > 3 times/ week
- Antihypertensive medication users
- People who have had hysterectomy
- Currently taking hormone replacement therapy or selective oestrogen receptor modulator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Inorganic Nitrate-rich Beetroot Juice on Microvascular Blood Flow, Cognitive Function and Other Hemodynamic Outcomes in Postmenopausal Women
Cardiovascular disease (CVD) is one of the leading causes of mortality worldwide. Inorganic nitrate found in beetroot and green leafy vegetables has been demonstrated to reduce cardiovascular disease risk factors including reducing blood pressure and the stiffness of blood vessels by increasing levels of a compound called nitric oxide. Much of the research to date has focused on the large blood vessels, and little is known about the impact of inorganic nitrate on smaller blood vessels which could be related to cognitive function.
The majority of beneficial effects with inorganic nitrate have been observed within young healthy populations. However, it is known that after the menopause women are at an increased risk of cardiovascular disease and have reduced levels of nitric oxide in their body; this could also contribute to the cognitive decline also observed post-menopause. This trial will investigate the impact of inorganic nitrate from beetroot juice on the blood flow in small blood vessels and on cognitive function in postmenopausal women. The hypothesis of the study is that the nitrate in beetroot juice will increase circulating nitric oxide that will then increase blood flow in small blood vessels and improve cognitive function.
- Conditions
- Post Menopausal
- Being tested
- Concentrated beetroot juice, Nitrate depleted beetroot juice + potassium nitrate (KNO3), Nitrate depleted beetroot juice
- Keywords
- Beetroot, NO, Nitrate, Microvascular function, Cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concentrated beetroot juiceDietary supplement
Subjects will consume 70ml shot (Beet-it Sport nitrate 400 shot, James White Drinks) and this drink contains 0.4g inorganic nitrate
Nitrate depleted beetroot juice + potassium nitrate (KNO3)Dietary supplement
Nitrate-depleted beetroot juice (70ml) and 0.4g KNO3- will be mixed. (Same appearance and taste with Beet-it sport shot)
Nitrate depleted beetroot juiceDietary supplement
Subjects will consume 70ml of (Beet-it Placebo shot, James White Drinks). This drink is the same as the Beet-it Sport nitrate shot but has the nitrate removed.
| Study group | Role | What they receive |
|---|---|---|
| Concentrated beetroot juice | Active comparator | Not described Receives: Dietary Supplement: Concentrated beetroot juice |
| Nitrate depleted beetroot juice + potassium nitrate (KNO3) | Active comparator | Not described Receives: Dietary Supplement: Nitrate depleted beetroot juice + potassium nitrate (KNO3) |
| Nitrate-depleted beetroot juice | Placebo comparator | Not described Receives: Dietary Supplement: Nitrate depleted beetroot juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline endothelial dependent microvascular function as laser Doppler imaging (LDI) with iontophoresis
Measurements will be taken by LDI with iontophoresis of endothelium-dependent (acetylcholine (ACh))
Measured: At baseline (t= 0.5 hours) and t= 3 hours
Change from baseline endothelial independent microvascular function as laser Doppler imaging (LDI) with iontophoresis
Measurements will be taken by LDI of endothelium-independent (sodium nitroprusside (SNP))
Measured: At baseline (t= 0.5 hours) and t= 3 hours
Change from baseline cognitive function. Domain: Episodic memory
-Rey Auditory Verbal Learning Test (RAVLT) task
Cognitive domains will be assessed by using the Gorilla online research tools.
Measured: At baseline (t= 0 hours) and t=2.5 hours
Change from baseline cognitive function. Domain: Executive function 1
-Digit Span Task
Measured: At baseline (t= 0 hours) and t=2.5 hours
Change from baseline cognitive function. Domain: Executive function 2
-Stroop Task
Measured: At baseline (t= 0 hours) and t=2.5 hours
Secondary outcomes (1)
Change in blood pressure
Systolic and Diastolic Blood pressure measurement by automated device
Measured: [Time Frame: At baseline (t= 0 hours) and 15 minute intervals until t= 2.5 hours.]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start14 Mar 2023
- Primary completion7 Jul 2023
- Study completion7 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post MenopausalStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charlotte E Mills, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05810974
- Sponsor's protocol ID
- -TBC-
- Status last verified
- Apr 2023
- First submitted
- 8 Feb 2023
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Inorganic Nitrate-rich Beetroot Juice on Microvascular Blood Flow, Cognitive Function and Other Hemodynamic Outcomes in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT05810974
- Acronym / sponsor ID
- -TBC-
- Conditions
- Post Menopausal
- Keywords
- Beetroot, NO, Nitrate, Microvascular function, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 7 Aug 2023 (actual)
- First posted
- 13 Apr 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.
Cardiovascular disease (CVD) is one of the leading causes of mortality worldwide. Inorganic nitrate found in beetroot and green leafy vegetables has been demonstrated to reduce cardiovascular disease risk factors including reducing blood pressure and the stiffness of blood vessels by increasing levels of a compound called nitric oxide. Much of the research to date has focused on the large blood vessels, and little is known about the impact of inorganic nitrate on smaller blood vessels which could be related to cognitive function.
The majority of beneficial effects with inorganic nitrate have been observed within young healthy populations. However, it is known that after the menopause women are at an increased risk of cardiovascular disease and have reduced levels of nitric oxide in their body; this could also contribute to the cognitive decline also observed post-menopause. This trial will investigate the impact of inorganic nitrate from beetroot juice on the blood flow in small blood vessels and on cognitive function in postmenopausal women. The hypothesis of the study is that the nitrate in beetroot juice will increase circulating nitric oxide that will then increase blood flow in small blood vessels and improve cognitive function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Concentrated beetroot juice | Active comparator | Dietary Supplement: Concentrated beetroot juice |
| Nitrate depleted beetroot juice + potassium nitrate (KNO3) | Active comparator | Dietary Supplement: Nitrate depleted beetroot juice + potassium nitrate (KNO3) |
| Nitrate-depleted beetroot juice | Placebo comparator | Dietary Supplement: Nitrate depleted beetroot juice |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Apparently healthy post-menopausal women (age over 45)
- Able to understand information sheet and willing to comply with the study protocol and able to give informed consent
- Not having menstrual period for 12 months
Key exclusion criteria (10 listed)
- Blood pressure <90/60 or > 140/90 mmHg
- Medical history of myocardial infarction, angina, thrombosis, stroke, cancer, high cholesterol, liver, renal, respiratory or bowel diseases or diabetes or other endocrine disorder
- BMI>30
- Any tobacco and/or nicotine users (or quit within the last 6 months)
- Current use of antihypertensive medication
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 |
|---|---|---|
| Concentrated beetroot juiceSubjects will consume 70ml shot (Beet-it Sport nitrate 400 shot, James White Drinks) and this drink contains 0.4g inorganic nitrate | Dietary supplement | Concentrated beetroot juice |
| Nitrate depleted beetroot juice + potassium nitrate (KNO3)Nitrate-depleted beetroot juice (70ml) and 0.4g KNO3- will be mixed. (Same appearance and taste with Beet-it sport shot) | Dietary supplement | Nitrate depleted beetroot juice + potassium nitrate (KNO3) |
| Nitrate depleted beetroot juiceSubjects will consume 70ml of (Beet-it Placebo shot, James White Drinks). This drink is the same as the Beet-it Sport nitrate shot but has the nitrate removed. | Dietary supplement | Nitrate-depleted beetroot juice |
Primary outcome
Change from baseline endothelial dependent microvascular function as laser Doppler imaging (LDI) with iontophoresis
Time frame: At baseline (t= 0.5 hours) and t= 3 hours
Measurements will be taken by LDI with iontophoresis of endothelium-dependent (acetylcholine (ACh))
Change from baseline endothelial independent microvascular function as laser Doppler imaging (LDI) with iontophoresis
Time frame: At baseline (t= 0.5 hours) and t= 3 hours
Measurements will be taken by LDI of endothelium-independent (sodium nitroprusside (SNP))
Change from baseline cognitive function. Domain: Episodic memory
Time frame: At baseline (t= 0 hours) and t=2.5 hours
-Rey Auditory Verbal Learning Test (RAVLT) task Cognitive domains will be assessed by using the Gorilla online research tools.
Change from baseline cognitive function. Domain: Executive function 1
Time frame: At baseline (t= 0 hours) and t=2.5 hours
-Digit Span Task
Change from baseline cognitive function. Domain: Executive function 2
Time frame: At baseline (t= 0 hours) and t=2.5 hours
-Stroop Task
1 secondary outcome
Change in blood pressure
Time frame: [Time Frame: At baseline (t= 0 hours) and 15 minute intervals until t= 2.5 hours.]
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 22 Nov 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concentrated beetroot juice, Nitrate depleted beetroot juice + potassium nitrate (KNO3) and Nitrate depleted beetroot juice in people with Post Menopausal, run by University of Reading at 1 site in United Kingdom.
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 3 inclusion and 10 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 22 Nov 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 Kingdom. 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 from baseline endothelial dependent microvascular function as laser Doppler imaging (LDI) with iontophoresis (time frame: At baseline (t= 0.5 hours) and t= 3 hours). 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 22 Nov 2024.