Skip to main content
OpenTrials
Completed

NCT Number: NCT05810974

The Impact of Inorganic Nitrate-rich Beetroot Juice on Microvascular Blood Flow and Cognitive Function

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Post Menopausal

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Reading

Reading, UK, RG6 6AH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Concentrated beetroot juice

Dietary 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 juice

Dietary 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.

Primary outcomes

  1. 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))

  2. 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))

  3. 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.

  4. Change from baseline cognitive function. Domain: Executive function 1

    Time frame: At baseline (t= 0 hours) and t=2.5 hours

    -Digit Span Task

  5. Change from baseline cognitive function. Domain: Executive function 2

    Time frame: At baseline (t= 0 hours) and t=2.5 hours

    -Stroop Task

Secondary outcomes

  1. Change in blood pressure

    Time frame: [Time Frame: At baseline (t= 0 hours) and 15 minute intervals until t= 2.5 hours.]

    Systolic and Diastolic Blood pressure measurement by automated device

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Registry information

Official study title

The Impact of Inorganic Nitrate-rich Beetroot Juice on Microvascular Blood Flow, Cognitive Function and Other Hemodynamic Outcomes in Postmenopausal Women

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 13, 2023
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.