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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04887610
Other study ID # 20-11-008
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 20, 2021
Est. completion date November 15, 2022

Study information

Verified date March 2023
Source University of Guelph
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will examine two separate interventions: 1) the effects of ischemic preconditioning or 2) a high fat meal on the capacity of the brachial artery to overcome sympathetic activation and dilate during exercise (also known as functional sympatholysis). Participants will be asked to complete rhythmic handgrip exercise with and without the application of -20 mmHg lower body negative pressure to increase sympathetic activation. Doppler ultrasound will be used to continuously measure brachial artery blood flow. Participants will complete the handgrip exercise and lower body negative pressure before and after the applications of each interventions. Participants may elect to only complete one intervention rather than complete both protocols. Intervention one is active or control ischemic preconditioning. Intervention two is high or low fat meals.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date November 15, 2022
Est. primary completion date November 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - 18 years or older - Healthy Exclusion Criteria: - History of smoking (tobacco or cannabis), defined as any smoking within the past 3 months - Diagnosed cardiovascular or metabolic disease(s) - Recent musculoskeletal injury handgrip exercise - Prescription of chronic medications other than oral contraceptives - History of hypertension or presence of arrhythmia

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Ischemic preconditioning
Four 5-minute cycles of 200 mmHg cuff inflation of the brachial artery, each separated by 5-minutes deflated recovery (i.e. 40 minutes total time)
Ischemic preconditioning control
Four 5-minute cycles of 20 mmHg cuff inflation of the brachial artery, each separated by 5-minutes deflated recovery (i.e. 40 minutes total time)
Dietary Supplement:
Low fat meal
Meal containing 1006 calories, 1 g fat, 0.2 g saturated fat, 0 g trans fat, 20 mg cholesterol, 191 g carbohydrates, 60 g protein, 1560 mg sodium
High fat meal
Meal containing 1030 calories, 62 g fat, 23 g saturated fat, 0.5 g trans fat, 445 mg cholesterol, 76 g carbohydrates, 41 g protein, 2080 mg sodium.

Locations

Country Name City State
Canada University of Guelph - Human Cardiovascular Physiology Laboratory Guelph Ontario

Sponsors (1)

Lead Sponsor Collaborator
University of Guelph

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Forearm blood flow Doppler ultrasound - tested at rest and during rhythmic handgrip exercise with and without lower body negative pressure Baseline - Immediately before active and control interventions
Primary Forearm blood flow Doppler ultrasound - tested at rest and during rhythmic handgrip exercise with and without lower body negative pressure Immediately after active and control interventions (IPC only)
Primary Forearm blood flow Doppler ultrasound - tested at rest and during rhythmic handgrip exercise with and without lower body negative pressure 1 hour after active and control interventions (Diet intervention only)
Primary Forearm blood flow Doppler ultrasound - tested at rest and during rhythmic handgrip exercise with and without lower body negative pressure 2 hours after active and control interventions (Diet intervention only)
Primary Forearm blood flow Doppler ultrasound - tested at rest and during rhythmic handgrip exercise with and without lower body negative pressure 3 hours after active and control interventions (Diet intervention only)
Primary Forearm vascular conductance Blood flow divided by blood pressure - tested at rest and during rhythmic handgrip exercise with and without lower body negative pressure Baseline - Immediately before active and control interventions
Primary Forearm vascular conductance Blood flow divided by blood pressure - tested at rest and during rhythmic handgrip exercise with and without lower body negative pressure Immediately after active and control interventions (IPC only)
Primary Forearm vascular conductance Blood flow divided by blood pressure - tested at rest and during rhythmic handgrip exercise with and without lower body negative pressure 1 hour after active and control interventions (Diet intervention only)
Primary Forearm vascular conductance Blood flow divided by blood pressure - tested at rest and during rhythmic handgrip exercise with and without lower body negative pressure 2 hours after active and control interventions (Diet intervention only)
Primary Forearm vascular conductance Blood flow divided by blood pressure - tested at rest and during rhythmic handgrip exercise with and without lower body negative pressure 3 hours after active and control interventions (Diet intervention only)
Secondary Blood pressure Finger plethysmography - tested at rest and during rhythmic handgrip exercise with and without lower body negative pressure Baseline - Immediately before active and control interventions
Secondary Blood pressure Finger plethysmography - tested at rest and during rhythmic handgrip exercise with and without lower body negative pressure Immediately after active and control interventions (IPC only)
Secondary Blood pressure Finger plethysmography - tested at rest and during rhythmic handgrip exercise with and without lower body negative pressure 1 hour after active and control interventions (Diet intervention only)
Secondary Blood pressure Finger plethysmography - tested at rest and during rhythmic handgrip exercise with and without lower body negative pressure 2 hours after active and control interventions (Diet intervention only)
Secondary Blood pressure Finger plethysmography - tested at rest and during rhythmic handgrip exercise with and without lower body negative pressure 3 hours after active and control interventions (Diet intervention only)
Secondary Heart rate ECG - tested at rest and during rhythmic handgrip exercise with and without lower body negative pressure Baseline - Immediately before active and control interventions
Secondary Heart rate ECG - tested at rest and during rhythmic handgrip exercise with and without lower body negative pressure Immediately after active and control interventions (IPC only)
Secondary Heart rate ECG - tested at rest and during rhythmic handgrip exercise with and without lower body negative pressure 1 hour after active and control interventions (Diet intervention only)
Secondary Heart rate ECG - tested at rest and during rhythmic handgrip exercise with and without lower body negative pressure 2 hours after active and control interventions (Diet intervention only)
Secondary Heart rate ECG - tested at rest and during rhythmic handgrip exercise with and without lower body negative pressure 3 hours after active and control interventions (Diet intervention only)
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