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

NCT ID: NCT05810974

Last Updated: 2024-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-14

Study Completion Date

2023-08-07

Brief Summary

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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.

Detailed Description

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Conditions

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Post Menopausal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Concentrated beetroot juice

Group Type ACTIVE_COMPARATOR

Concentrated beetroot juice

Intervention Type 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)

Group Type ACTIVE_COMPARATOR

Nitrate depleted beetroot juice + potassium nitrate (KNO3)

Intervention Type 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

Group Type PLACEBO_COMPARATOR

Nitrate depleted beetroot juice

Intervention Type 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.

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

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)

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Reading

OTHER

Sponsor Role lead

Responsible Party

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Charlotte E Mills

Lecturer, Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Reading

Reading, UK, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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-TBC-

Identifier Type: -

Identifier Source: org_study_id

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