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

Post Menopausal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05810974
• Other study ID #: -TBC-
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 14, 2023
• Est. completion date: September 7, 2023

Study information

• Verified date: April 2023
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: September 7, 2023
• Est. primary completion date: July 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post Menopausal

Intervention

Dietary Supplement:
• Concentrated beetroot juice
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)
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
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.

Locations

Country	Name	City	State
United Kingdom	University of Reading	Reading	UK

Sponsors (1)

Lead Sponsor	Collaborator
University of Reading

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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))	At baseline (t= 0.5 hours) and t= 3 hours
Primary	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))	At baseline (t= 0.5 hours) and t= 3 hours
Primary	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.	At baseline (t= 0 hours) and t=2.5 hours
Primary	Change from baseline cognitive function. Domain: Executive function 1	-Digit Span Task	At baseline (t= 0 hours) and t=2.5 hours
Primary	Change from baseline cognitive function. Domain: Executive function 2	-Stroop Task	At baseline (t= 0 hours) and t=2.5 hours
Secondary	Change in blood pressure	Systolic and Diastolic Blood pressure measurement by automated device	[Time Frame: At baseline (t= 0 hours) and 15 minute intervals until t= 2.5 hours.]