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The Effects of Nitrate, Caffeine, and Cold Exposure on Cardiovascular Function.

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06602921
Enrollment
24
Registered
2024-09-19
Start date
2023-12-05
Completion date
2025-04-01
Last updated
2025-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caffeine, Cold Exposure, Nitrate

Keywords

Cardiovascular Function, Flow mediated dilation

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.

Interventions

DIETARY_SUPPLEMENTTruBeet inorganic beetroot juice

400 mg nitrate-rich beetroot powder, mixed with 300 mL water.

DIETARY_SUPPLEMENTCaffeine

6 mg/kg caffeine powder in capsule form.

OTHERCold pressor test

3 min cold pressor test using the left foot in cold water (0-2 degree).

Sponsors

Biogen Extracts Pvt Ltd
CollaboratorUNKNOWN
Loughborough University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Masking description

Double-blinded using supplement placebos.

Intervention model description

24 participants will complete 4 experimental conditions in a randomized order.

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* Blood pressure \< 130 mmHg systolic and \< 85 mmHg diastolic. BMI between 18.5 and 29.9 kg/m2. 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.

Design outcomes

Primary

MeasureTime frameDescription
Brachial blood pressureMean 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 dilationMeasured 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 variablesCollected 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

MeasureTime frameDescription
NIBP continuous blood pressureCollected 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).SBP, DBP, MAP, HR collected continuously for 3-5 min.
Heart rate variabilityCollected 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).Time and frequency domains for heart rate variability collected for 3-5min.
Plasma nitrate, nitrite, cGMPCollected 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 concentrations of nitrate, nitrite, and cGMP.
Whole blood RSNOCollected 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).S--nitrosothiols concentration from treated whole blood (NEM, EDTA, potassium ferricyanide).
Forearm blood flowMeasured 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).Forearm blood flow pre- and post-PORH (post occlusion reactive hyperaemia) via strain gauge plethysmography.
Salivary nitrate and nitriteMeasured 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 concentration of nitrate and nitrite

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026