Ischemic PreconditioningNCT04887610
Factors That Influence Blood Vessel Regulation During Exercise in Humans
A study testing Ischemic preconditioning, Low fat meal and High fat meal in people with Ischemic Preconditioning and Dietary Exposure, run by University of Guelph at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemic Preconditioning, Dietary Exposure
- What is being tested?
- Ischemic preconditioning, Low fat meal and High fat meal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 20 May 2021to 15 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 years or older
- Healthy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Guelph - Human Cardiovascular Physiology Laboratory
Guelph, Ontario, N1G 2W1
About this study
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.
- Conditions
- Ischemic Preconditioning, Dietary Exposure
- Being tested
- Ischemic preconditioning, Ischemic preconditioning control, Low fat meal, High fat meal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemic preconditioningProcedure or surgery
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 controlProcedure or surgery
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)
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 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.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic preconditioning control | Sham comparator | Not described Receives: Procedure: Ischemic preconditioning control |
| Ischemic preconditioning | Active comparator | Not described Receives: Procedure: Ischemic preconditioning |
| High fat meal | Active comparator | Not described Receives: Dietary Supplement: Low fat meal |
| Low fat meal | Placebo comparator | Not described Receives: Dietary Supplement: High fat meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forearm blood flow
Doppler ultrasound - tested at rest and during rhythmic handgrip exercise with and without lower body negative pressure
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 hours after active and control interventions (Diet intervention only)
Secondary outcomes (10)
Blood pressure
Finger plethysmography - tested at rest and during rhythmic handgrip exercise with and without lower body negative pressure
Measured: Baseline - Immediately before active and control interventions
Blood pressure
Finger plethysmography - tested at rest and during rhythmic handgrip exercise with and without lower body negative pressure
Measured: Immediately after active and control interventions (IPC only)
Blood pressure
Finger plethysmography - tested at rest and during rhythmic handgrip exercise with and without lower body negative pressure
Measured: 1 hour after active and control interventions (Diet intervention only)
Blood pressure
Finger plethysmography - tested at rest and during rhythmic handgrip exercise with and without lower body negative pressure
Measured: 2 hours after active and control interventions (Diet intervention only)
Blood pressure
Finger plethysmography - tested at rest and during rhythmic handgrip exercise with and without lower body negative pressure
Measured: 3 hours after active and control interventions (Diet intervention only)
Heart rate
ECG - tested at rest and during rhythmic handgrip exercise with and without lower body negative pressure
Measured: Baseline - Immediately before active and control interventions
Heart rate
ECG - tested at rest and during rhythmic handgrip exercise with and without lower body negative pressure
Measured: Immediately after active and control interventions (IPC only)
Heart rate
ECG - tested at rest and during rhythmic handgrip exercise with and without lower body negative pressure
Measured: 1 hour after active and control interventions (Diet intervention only)
Heart rate
ECG - tested at rest and during rhythmic handgrip exercise with and without lower body negative pressure
Measured: 2 hours after active and control interventions (Diet intervention only)
Heart rate
ECG - tested at rest and during rhythmic handgrip exercise with and without lower body negative pressure
Measured: 3 hours after active and control interventions (Diet intervention only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start20 May 2021
- Primary completion15 Nov 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic PreconditioningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Millar, University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887610
- Sponsor's protocol ID
- 20-11-008
- Status last verified
- Mar 2023
- First submitted
- 1 Apr 2021
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36878187
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors That Influence Blood Vessel Regulation During Exercise in Humans
- ClinicalTrials.gov ID
- NCT04887610
- Acronym / sponsor ID
- 20-11-008
- Conditions
- Ischemic Preconditioning, Dietary Exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 14 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18 years or older
- Healthy
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ischemic preconditioningFour 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) | Procedure or surgery | Ischemic preconditioning |
| Ischemic preconditioning controlFour 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) | Procedure or surgery | Ischemic preconditioning control |
| Low fat mealMeal 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 | Dietary supplement | High fat meal |
| High fat mealMeal 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. | Dietary supplement | Low fat meal |
Primary outcome
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
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
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
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
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
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
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
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
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
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
10 secondary outcomes
Blood pressure
Time frame: Baseline - Immediately before active and control interventions
Blood pressure
Time frame: Immediately after active and control interventions (IPC only)
Blood pressure
Time frame: 1 hour after active and control interventions (Diet intervention only)
Blood pressure
Time frame: 2 hours after active and control interventions (Diet intervention only)
Blood pressure
Time frame: 3 hours after active and control interventions (Diet intervention only)
Heart rate
Time frame: Baseline - Immediately before active and control interventions
Heart rate
Time frame: Immediately after active and control interventions (IPC only)
Heart rate
Time frame: 1 hour after active and control interventions (Diet intervention only)
Heart rate
Time frame: 2 hours after active and control interventions (Diet intervention only)
Heart rate
Time frame: 3 hours after active and control interventions (Diet intervention only)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Derived from this study: PubMed 36878187Teixeira 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ischemic preconditioning, Low fat meal and High fat meal in people with Ischemic Preconditioning and Dietary Exposure, run by University of Guelph at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forearm blood flow (time frame: Baseline - Immediately before active and control interventions). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04887610, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.