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Clinical Trials/NCT06602921
NCT06602921CompletedNot Applicable

Does Dietary Nitrate Supplementation Attenuate the Cardiovascular Strain Elicited by Caffeine and Cold Exposure in Healthy Individuals?

Loughborough University2 sites in 1 country24 target enrollmentStarted: December 5, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
24
Locations
2
Primary Endpoint
Brachial blood pressure

Study Overview

Brief Summary

Dietary inorganic nitrate supplementation may have positive implications on cardiovascular function. The aim of this project is to determine if nitrate supplementation can attenuate the effects that caffeine and cold exposure have on the cardiovascular system.

Detailed Description

Acute caffeine consumption and cold exposure elicit negative effects on the cardiovascular system. Humans are regularly exposed to such conditions of increased cardiovascular strain, which may lead to elevated chronic cardiovascular risk. On the other hand, dietary inorganic nitrate supplementation is well established to improve cardiovascular function in healthy individuals. Thus, acute nitrate supplementation may compensate for the negative effects that caffeine and the cold place on the cardiovascular system. These effects will be measured using peripheral blood pressure, pulse wave analysis, heart rate variability, forearm blood flow, flow mediated dilation, and blood and saliva markers.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Masking Description

Double-blinded using supplement placebos.

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Blood pressure < 130 mmHg systolic and < 85 mmHg diastolic. BMI between 18.5 and 29.9 kg/m
  • Females must be naturally menstruating (regular length cycle and menses) or using a form of combined hormonal contraception (for at least 6 months).

Exclusion Criteria

  • Existing cardiovascular or metabolic conditions. Experience any adverse reactions to experimental procedures or supplements. Allergies to supplements or breakfast items. Involved in any other studies. Blood pressure > 130 mmHg systolic and > 85 mmHg diastolic.

Outcomes

Primary Outcomes

Brachial blood pressure

Time Frame: Mean of 5 readings taken pre-supplementation (0 hours) and post-supplementation (2.5 hours). 1 reading was taken pre- cold pressor test (3.5 hours). All measures were recorded on every experimental trial (4 trials with at least 48 h washout between).

Brachial blood pressure was collected using an automatic sphygmomanometer.

Flow mediated dilation

Time Frame: Measured pre-supplementation (at 0 hours) and post-supplementation (at 2.5 hours) for every experimental trial (4 trials with at least 48 h washout between).

Baseline diameter, peak diameter, change in diameter, and shear stimulus following flow mediated dilation procedure of the brachial artery with post-occlusion reactive hyperaemia.

Central blood pressure and pulse wave variables

Time Frame: Collected pre-supplementation (0 hours), post-supplementation (2.5 hours), and during the cold pressor test (3.5 h) for 4 experimental trials (4 trials with at least 48 hours washout in between).

Mean of 2-3 readings for aortic systolic BP, aortic diastolic BP, HR, Augmentation index, augmentation index corrected to HR of 75 bpm, pulse pressure, and augmentation pressure.

Secondary Outcomes

  • Forearm blood flow(Measured pre-supplementation (at 0 hours) and post-supplementation (at 2.5 hours) for every experimental trial (4 trials with at least 48 h washout between).)
  • Salivary nitrate and nitrite(Measured pre-supplementation (at 0 hours) and post-supplementation (at 2.5 hours) for every experimental trial (4 trials with at least 48 h washout between).)
  • Heart rate variability(Collected pre-supplementation (0 hours), post-supplementation (2.5 hours), and during the cold pressor test (3.5 h) for 4 experimental trials (4 trials with at least 48 hours washout in between).)
  • NIBP continuous blood pressure(Collected pre-supplementation (0 hours), post-supplementation (2.5 hours), and during the cold pressor test (3.5 h) for 4 experimental trials (4 trials with at least 48 hours washout in between).)
  • Whole blood RSNO(Collected pre-supplementation (0 hours), post-supplementation (2.5 hours), and immediately post- cold pressor test (3.5 h) for 4 experimental trials (4 trials with at least 48 hours washout in between).)
  • Plasma nitrate, nitrite, cGMP(Collected pre-supplementation (0 hours), post-supplementation (2.5 hours), and immediately post- cold pressor test (3.5 h) for 4 experimental trials (4 trials with at least 48 hours washout in between))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Stephen Bailey

Principal Investigator

Loughborough University

Study Sites (2)

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