Factors That Influence Blood Vessel Regulation During Exercise in Humans

Dietary Exposure Clinical Trial

Official title:

Factors That Influence Blood Vessel Regulation During Exercise in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04887610
• Other study ID #: 20-11-008
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Dietary Exposure
• Ischemic Preconditioning

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)