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Completed

NCT Number: NCT05514821

Inter-individual Variation in the Blood Pressure Lowering Effects of Dietary Nitrate

Dietary nitrate supplementation, often in the form of beetroot juice, has been shown to lower blood pressure and could play a role in preventing or treating hypertension. However, it is currently unclear: a) how reproducible this response is within the same individual on different occasions, and b) whether there are genuine individual differences in the blood pressure lowering effects of dietary nitrate. This study will use a novel replicated cross-over design (2 x nitrate conditions, 2 x placebo conditions) to examine the reproducibility and inter-individual variability in the blood pressure lowering effects of dietary nitrate supplementation.

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Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Human Nutrition & Exercise Research Centre

Newcastle upon Tyne, Northumberland, NE24HH, United Kingdom

About this study

The investigators will undertake a replicated cross-over randomised controlled trial (i.e., a study involving 2 x identical experimental conditions and 2 x identical control conditions), to explore the reproducibility of the blood pressure lowering effects of nitrate-rich beetroot juice, and to identify if there are genuine individual differences in the blood pressure-lowering effects of this supplement. Participants will be recruited via posters, email and social media, and interested individuals will be invited to attend the laboratory on 5 occasions.

Visit 1: Potential participants will be invited to attend a screening session at Newcastle University to identify if they are eligible to participate. They will have an opportunity to discuss the study with a researcher and will provide written consent. They will then complete a screening questionnaire and provide a measure of their height, weight and blood pressure. Eligible participants will be invited to attend 4 experimental trials (2 x nitrate-rich beetroot juice conditions, 2 x placebo conditions) over 2-3 weeks with a minimum of 3 days wash-out between visits. If individuals are ineligible to participate this will be explained to them and they will be thanked for their time.

Visits 2-5: On the day before the first trial, participants will be asked to record what they eat and then replicate this as closely as possible for all future visits. In the morning of each trial, participants will be asked to arrive at the laboratory between 7-9 am having fasted since 10 pm the night before. The participants will be required to rest for 10 minutes, after which a measure of their blood pressure will be obtained. Participants will then be provided with breakfast (a bowl of porridge) and 140 ml concentrated nitrate-rich (~12.5 mmol nitrate) or nitrate-depleted beetroot juice (~0 mmol nitrate). Participants will then be asked to sit in the laboratory for 2.5 hours, during which time they can read quietly or use a computer. The investigators will then obtain a further measure of their blood pressure and collect a blood sample from a vein in their arm via venepuncture, to measure markers of nitric oxide, a signalling molecule in the body which is thought to mediate the blood pressure lowering effects of nitrate-rich beetroot juice.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male volunteers
  • Aged 18 - 45 years

Exclusion criteria

  • Aged less than 18 or more than 45 years old
  • Female
  • Currently taking any medication or antibiotics
  • Attending general practitioner for a health problem or on a hospital waiting list
  • Currently taking part in another research study which could conflict with the requirements for this investigation
  • Regularly use antibacterial mouthwash and unwilling to stop using this throughout the study period
  • Current smoker
  • History of kidney, liver or cardiovascular disease
  • Have diabetes
  • Have a gastrointestinal disorder
  • Recent history (past 1 year) of cancer
  • Use of other dietary supplements e.g., pre and probiotics
  • Currently dieting
  • Have a known allergy to any components within the dietary supplement

Treatment and study plan

Beet It Sport Shot

Dietary Supplement

Acute supplementation with 140 ml Beet It Sport Shots, James White Ltd, containing ~400mg dietary nitrate

Beet It Sport Shot Placebo

Dietary Supplement

Acute supplementation with 140 ml Beet It Sport Shots Placebo, James White Ltd, in which the nitrate has been removed via an ion exchange resin, containing ~ 0 mg dietary nitrate

Primary outcomes

  1. Blood pressure of the brachial artery

    Time frame: Immediately prior to supplementation and for 2.5 hours after supplementation

    Blood pressure of the brachial artery

Secondary outcomes

  1. Plasma nitrite concentrations

    Time frame: 2.5 hours after supplementation

    Plasma nitrite concentrations

Sponsors and collaborators

Lead sponsor

Newcastle University

Other

Collaborators

  • Aspire Academy
  • Liverpool John Moores University
  • University of Nottingham
  • University of the West of Scotland

Registry information

Official study title

Effects of Dietary Nitrate on Blood Pressure: Exploring the Repeatability and Inter-individual Variation in Responses

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 24, 2022
Registry last updated
Dec 5, 2023

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.

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