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

NCT05514821 | Completed

• 1 other identifier: NU013253
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blood Pressure

Keywords

Hypertension; Personalized nutrition; Nitric oxide; Beetroot juice

Outcome Measures

Primary Outcomes (1)

• Blood pressure of the brachial artery

  Blood pressure of the brachial artery

  Immediately prior to supplementation and for 2.5 hours after supplementation

Secondary Outcomes (1)

• Plasma nitrite concentrations

  2.5 hours after supplementation

Study Arms (4)

Experimental condition 1

EXPERIMENTAL

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

Dietary Supplement: Beet It Sport Shot

Experimental condition 2

EXPERIMENTAL

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

Dietary Supplement: Beet It Sport Shot

Control condition 1

PLACEBO COMPARATOR

Acute supplementation with 140 ml nitrate-depleted Beet It Sport Shots, James White Ltd (\~0mg dietary nitrate)

Dietary Supplement: Beet It Sport Shot Placebo

Control condition 2

PLACEBO COMPARATOR

Acute supplementation with 140 ml nitrate-depleted Beet It Sport Shots, James White Ltd (\~0mg dietary nitrate)

Dietary Supplement: Beet It Sport Shot Placebo

Interventions

Beet It Sport Shot DIETARY_SUPPLEMENT

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

Experimental condition 1; Experimental condition 2

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

Control condition 1; Control condition 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male volunteers
• Aged 18 - 45 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Newcastle University: lead
• University of the West of Scotland: collaborator
• University of Nottingham: collaborator
• Aspire Academy: collaborator
• Liverpool John Moores University: collaborator

Study Sites (1)

Human Nutrition & Exercise Research Centre

Newcastle upon Tyne, Northumberland, NE24HH, United Kingdom

Location

Related Publications (1)

• Hayes E, Alhulaefi S, Siervo M, Whyte E, Kimble R, Matu J, Griffiths A, Sim M, Burleigh M, Easton C, Lolli L, Atkinson G, Mathers JC, Shannon OM. Inter-individual differences in the blood pressure lowering effects of dietary nitrate: a randomised double-blind placebo-controlled replicate crossover trial. Eur J Nutr. 2025 Feb 24;64(2):101. doi: 10.1007/s00394-025-03616-x.

  PMID: 39992469 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Oliver Shannon, PhD

  Newcastle University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Supplements will be administered double blind (participant and researcher blind) in identical bottles. They will be identical in smell, taste, texture and colour.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Replicated cross-over trial

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 24, 2022
• Study Start: October 15, 2022
• Primary Completion: September 25, 2023
• Study Completion: September 25, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Within 6 months of publication of the study findings

Locations

GB (1)