Clinical trial NCT05810974: The Impact of Inorganic Nitrate-rich Beetroot Juice on Microvascular Blood Flow and Cognitive Function
Official title: The Impact of Inorganic Nitrate-rich Beetroot Juice on Microvascular Blood Flow, Cognitive Function and Other Hemodynamic Outcomes in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Menopausal
Keywords: Beetroot
NO
Nitrate
Microvascular function
Cognition
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 20
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Vigorous exercise \> 3 times/ week
* Antihypertensive medication users
* People who have had hysterectomy
* Currently taking hormone replacement therapy or selective oestrogen receptor modulator

Primary outcomes:
measure: Change from baseline endothelial dependent microvascular function as laser Doppler imaging (LDI) with iontophoresis
timeFrame: At baseline (t= 0.5 hours) and t= 3 hours
measure: Change from baseline endothelial independent microvascular function as laser Doppler imaging (LDI) with iontophoresis
timeFrame: At baseline (t= 0.5 hours) and t= 3 hours
measure: Change from baseline cognitive function. Domain: Episodic memory
timeFrame: At baseline (t= 0 hours) and t=2.5 hours
measure: Change from baseline cognitive function. Domain: Executive function 1
timeFrame: At baseline (t= 0 hours) and t=2.5 hours
measure: Change from baseline cognitive function. Domain: Executive function 2
timeFrame: At baseline (t= 0 hours) and t=2.5 hours
Secondary outcomes:
measure: Change in blood pressure
timeFrame: [Time Frame: At baseline (t= 0 hours) and 15 minute intervals until t= 2.5 hours.]
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: University of Reading
state: UK
Study officials:
References: