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

What this trial studies

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.

Conditions in scope

• Post Menopausal

Interventions

• 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.

Who can join

Women only · Ages 45 Years and up · Accepts healthy volunteers.

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: N/A
• Start date: 2023-03-14
• Primary completion: 2023-07-07
• Last update posted: 2024-11-22
• First posted: 2023-04-13

Sponsor & contact

Lead sponsor: University of Reading (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Change from baseline endothelial dependent microvascular function as laser Doppler imaging (LDI) with iontophoresis (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 (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 (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 (At baseline (t= 0 hours) and t=2.5 hours)
  -Digit Span Task
• Change from baseline cognitive function. Domain: Executive function 2 (At baseline (t= 0 hours) and t=2.5 hours)
  -Stroop Task

Related ClearedRx care

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