Factors That Influence Blood Vessel Regulation During Exercise in Humans

March 27, 2023 updated by: Philip Millar, University of Guelph
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Guelph, Ontario, Canada, N1G 2W1
        • University of Guelph - Human Cardiovascular Physiology Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: High fat meal
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
Sham Comparator: Ischemic preconditioning control
Procedure: 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)
Active Comparator: Ischemic preconditioning
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)
Placebo Comparator: Low fat meal
Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Forearm blood flow
Time Frame: Baseline - Immediately before active and control interventions
Doppler ultrasound - tested at rest and during rhythmic handgrip exercise with and without lower body negative pressure
Baseline - Immediately before active and control interventions
Forearm vascular conductance
Time Frame: Baseline - Immediately before active and control interventions
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
Forearm blood flow
Time Frame: Immediately after active and control interventions (IPC only)
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)
Forearm blood flow
Time Frame: 1 hour after active and control interventions (Diet intervention only)
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)
Forearm blood flow
Time Frame: 2 hours after active and control interventions (Diet intervention only)
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)
Forearm blood flow
Time Frame: 3 hours after active and control interventions (Diet intervention only)
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)
Forearm vascular conductance
Time Frame: Immediately after active and control interventions (IPC only)
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)
Forearm vascular conductance
Time Frame: 1 hour after active and control interventions (Diet intervention only)
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)
Forearm vascular conductance
Time Frame: 2 hours after active and control interventions (Diet intervention only)
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)
Forearm vascular conductance
Time Frame: 3 hours after active and control interventions (Diet intervention only)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: Baseline - Immediately before active and control interventions
Finger plethysmography - tested at rest and during rhythmic handgrip exercise with and without lower body negative pressure
Baseline - Immediately before active and control interventions
Heart rate
Time Frame: Baseline - Immediately before active and control interventions
ECG - tested at rest and during rhythmic handgrip exercise with and without lower body negative pressure
Baseline - Immediately before active and control interventions
Blood pressure
Time Frame: Immediately after active and control interventions (IPC only)
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)
Blood pressure
Time Frame: 1 hour after active and control interventions (Diet intervention only)
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)
Blood pressure
Time Frame: 2 hours after active and control interventions (Diet intervention only)
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)
Blood pressure
Time Frame: 3 hours after active and control interventions (Diet intervention only)
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)
Heart rate
Time Frame: Immediately after active and control interventions (IPC only)
ECG - tested at rest and during rhythmic handgrip exercise with and without lower body negative pressure
Immediately after active and control interventions (IPC only)
Heart rate
Time Frame: 1 hour after active and control interventions (Diet intervention only)
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)
Heart rate
Time Frame: 2 hours after active and control interventions (Diet intervention only)
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)
Heart rate
Time Frame: 3 hours after active and control interventions (Diet intervention only)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Guelph

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20-11-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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