NCT04887610

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 14, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

May 20, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

1.5 years

First QC Date

April 1, 2021

Last Update Submit

March 27, 2023

Conditions

Ischemic PreconditioningDietary Exposure

Outcome Measures

Primary Outcomes (10)

  • 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

  • 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)

  • 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)

  • 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)

  • 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)

  • 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

  • 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)

  • 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)

  • 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)

  • 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 Outcomes (10)

  • Blood pressure

    Baseline - Immediately before active and control interventions

  • Blood pressure

    Immediately after active and control interventions (IPC only)

  • Blood pressure

    1 hour after active and control interventions (Diet intervention only)

  • Blood pressure

    2 hours after active and control interventions (Diet intervention only)

  • Blood pressure

    3 hours after active and control interventions (Diet intervention only)

  • +5 more secondary outcomes

Study Arms (4)

Ischemic preconditioning control

SHAM COMPARATOR
Procedure: Ischemic preconditioning control

Ischemic preconditioning

ACTIVE COMPARATOR
Procedure: Ischemic preconditioning

High fat meal

ACTIVE COMPARATOR
Dietary Supplement: Low fat meal

Low fat meal

PLACEBO COMPARATOR
Dietary Supplement: High fat meal

Interventions

Ischemic preconditioningPROCEDURE

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
Ischemic preconditioning controlPROCEDURE

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)

Ischemic preconditioning control
Low fat mealDIETARY_SUPPLEMENT

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
High fat mealDIETARY_SUPPLEMENT

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.

Low fat meal

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years or older
  • Healthy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Guelph - Human Cardiovascular Physiology Laboratory

Guelph, Ontario, N1G 2W1, Canada

Location

Related Publications (1)

  • Teixeira AL, Gangat A, Bommarito JC, Burr JF, Millar PJ. Ischemic Preconditioning Acutely Improves Functional Sympatholysis during Handgrip Exercise in Healthy Males but not Females. Med Sci Sports Exerc. 2023 Jul 1;55(7):1250-1257. doi: 10.1249/MSS.0000000000003148. Epub 2023 Feb 24.

    PMID: 36878187DERIVED

MeSH Terms

Interventions

Ischemic Preconditioning

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 1, 2021

First Posted

May 14, 2021

Study Start

May 20, 2021

Primary Completion

November 15, 2022

Study Completion

November 15, 2022

Last Updated

March 30, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)