Diet, HealthyNCT06186050
Effects of a High-fat Meal on Exercise-mediated Sympatholysis
A study testing Beetroot drink in people with Diet, Healthy, run by University of Guelph at 1 site in Canada.
Trial summary
The goal of this trial is to examine the effects of a single high-fat meal with or without the co-ingestion of dietary nitrate on exercise-mediated sympatholysis. The main questions it aims to answer are: 1. What are the mechanisms responsible for reduced exercise-mediated sympatholysis following a high-fat meal 2. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy
- What is being tested?
- Beetroot drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jan 2024to 30 Jul 2024
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-30 years of age
- Healthy, free of known cardiovascular, metabolic, or musculoskeletal disease
Who cannot join
- Diagnosed cardiovascular or metabolic disease, injury preventing handgrip exercise, prescription of chronic medications other than oral contraceptives.
- Inability to abstain from drugs (except oral contraceptives), caffeine, alcohol, strenuous physical activity, mouthwash, and multivitamins prior to study
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Guelph - Human Cardiovascular Physiology Laboratory
Guelph, Ontario, N1G2W1
About this study
The goal of this trial is to examine the effects of a single high-fat meal with or without the co-ingestion of dietary nitrate on exercise-mediated sympatholysis. The main questions it aims to answer are:
- What are the mechanisms responsible for reduced exercise-mediated sympatholysis following a high-fat meal
- Can dietary nitrate prevent the declines in exercise-mediated sympatholysis
Read more
Participants will be asked to complete three study visits in a randomized order:
- Low-fat meal
- High-fat meal
- High-fat meal plus dietary nitrate
Exercise-mediated sympatholysis will be measured using Doppler ultrasound via a protocol involving rhythmic handgrip exercise and a lower body negative pressure stimulus. Sympatholysis will be assessed before each meal, and at 1, 2, and 3 hours post-prandial.
- Conditions
- Diet, Healthy
- Being tested
- Beetroot drink, Placebo, Control
- Keywords
- Functional sympatholysis, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot drinkDietary supplement
Also called Superbeets
Drink containing 10g of beetroot powder in 250 mL cold tap water
PlaceboDietary supplement
Also called Mio
Mio flavouring in 250 mL cold tap water. Trace amounts of sugar and sodium were added to match the content in the beetroot supplement
ControlDietary supplement
Low-fat meal with cornflakes, greek yogurt, skim milk, and orange juice
| Study group | Role | What they receive |
|---|---|---|
| High-fat meal with Beetroot Drink | Active comparator | 2 sausage egg McMuffins and a hashbrown from McDonalds and 10g of beetroot powder mixed in 250 mL cold tap water drink Receives: Dietary Supplement: Beetroot drink |
| High-fat meal with Placebo Drink | Placebo comparator | 2 sausage egg McMuffins and a hashbrown from McDonalds and Mio water flavouring in 250 mL cold tap water. Trace amounts of sugar and sodium were mixed to match the beetroot supplement Receives: Dietary Supplement: Placebo |
| Low-fat meal control | Sham comparator | Kelloggs cornflakes (110g), greek yogurt (400g), skim milk (500 mL), and orange juice (250 mL). Energy-matched to the high-fat meal Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forearm vascular conductance
Duplex ultrasound of brachial artery
Measured: Before intervention and 1, 2, 3 hours post-intervention
Forearm blood flow
Duplex ultrasound of brachial artery
Measured: Before intervention and 1, 2, 3 hours post-intervention
Systolic and Diastolic Blood Pressure
finger plethysmography
Measured: Before intervention and 1, 2, 3 hours post-intervention
Secondary outcomes (4)
Plasma levels of Norepinephrine
ELISA kit
Measured: Blood collected before intervention and 1, 2, 3 hours post-intervention. Blood frozen at -80 degrees Celsius and analyzed at later date
Plasma levels of Nitrate/Nitrite concentration
ELISA kit
Measured: Blood collected before intervention and 1, 2, 3 hours post-intervention. Blood frozen at -80 degrees Celsius and analyzed at later date
Blood Glucose concentrations
Blood glucose monitor
Measured: Blood collected before intervention and 1, 2, 3 hours post-intervention. Blood analyzed immediately after collection at each time point
Plasma levels of Triglycerides
Triglyceride assay kit
Measured: Blood collected before intervention and 1, 2, 3 hours post-intervention. Blood frozen at -80 degrees Celsius and analyzed at later date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start8 Jan 2024
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 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
- Investigators
- Philip Millar, PhD, Principal investigator, University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186050
- Sponsor's protocol ID
- 23-01-017
- Status last verified
- Sep 2024
- First submitted
- 15 Dec 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a High-fat Meal on Exercise-mediated Sympatholysis
- ClinicalTrials.gov ID
- NCT06186050
- Acronym / sponsor ID
- 23-01-017
- Conditions
- Diet, Healthy
- Keywords
- Functional sympatholysis, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 29 Dec 2023 (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.
The goal of this trial is to examine the effects of a single high-fat meal with or without the co-ingestion of dietary nitrate on exercise-mediated sympatholysis. The main questions it aims to answer are:
- What are the mechanisms responsible for reduced exercise-mediated sympatholysis following a high-fat meal
- Can dietary nitrate prevent the declines in exercise-mediated sympatholysis
Participants will be asked to complete three study visits in a randomized order:
- Low-fat meal
- High-fat meal
- High-fat meal plus dietary nitrate
Exercise-mediated sympatholysis will be measured using Doppler ultrasound via a protocol involving rhythmic handgrip exercise and a lower body negative pressure stimulus. Sympatholysis will be assessed before each meal, and at 1, 2, and 3 hours post-prandial.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-fat meal with Beetroot Drink | Active comparator | Dietary Supplement: Beetroot drink2 sausage egg McMuffins and a hashbrown from McDonalds and 10g of beetroot powder mixed in 250 mL cold tap water drink |
| High-fat meal with Placebo Drink | Placebo comparator | Dietary Supplement: Placebo2 sausage egg McMuffins and a hashbrown from McDonalds and Mio water flavouring in 250 mL cold tap water. Trace amounts of sugar and sodium were mixed to match the beetroot supplement |
| Low-fat meal control | Sham comparator | Dietary Supplement: ControlKelloggs cornflakes (110g), greek yogurt (400g), skim milk (500 mL), and orange juice (250 mL). Energy-matched to the high-fat meal |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-30 years of age
- Healthy, free of known cardiovascular, metabolic, or musculoskeletal disease
Key exclusion criteria (2 listed)
- Diagnosed cardiovascular or metabolic disease, injury preventing handgrip exercise, prescription of chronic medications other than oral contraceptives.
- Inability to abstain from drugs (except oral contraceptives), caffeine, alcohol, strenuous physical activity, mouthwash, and multivitamins prior to study
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 |
|---|---|---|
| Beetroot drinkAlso: SuperbeetsDrink containing 10g of beetroot powder in 250 mL cold tap water | Dietary supplement | High-fat meal with Beetroot Drink |
| PlaceboAlso: MioMio flavouring in 250 mL cold tap water. Trace amounts of sugar and sodium were added to match the content in the beetroot supplement | Dietary supplement | High-fat meal with Placebo Drink |
| ControlLow-fat meal with cornflakes, greek yogurt, skim milk, and orange juice | Dietary supplement | Low-fat meal control |
Primary outcome
Forearm vascular conductance
Time frame: Before intervention and 1, 2, 3 hours post-intervention
Duplex ultrasound of brachial artery
Forearm blood flow
Time frame: Before intervention and 1, 2, 3 hours post-intervention
Duplex ultrasound of brachial artery
Systolic and Diastolic Blood Pressure
Time frame: Before intervention and 1, 2, 3 hours post-intervention
finger plethysmography
4 secondary outcomes
Plasma levels of Norepinephrine
Time frame: Blood collected before intervention and 1, 2, 3 hours post-intervention. Blood frozen at -80 degrees Celsius and analyzed at later date
Plasma levels of Nitrate/Nitrite concentration
Time frame: Blood collected before intervention and 1, 2, 3 hours post-intervention. Blood frozen at -80 degrees Celsius and analyzed at later date
Blood Glucose concentrations
Time frame: Blood collected before intervention and 1, 2, 3 hours post-intervention. Blood analyzed immediately after collection at each time point
Plasma levels of Triglycerides
Time frame: Blood collected before intervention and 1, 2, 3 hours post-intervention. Blood frozen at -80 degrees Celsius and analyzed at later date
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 19 Sep 2024.
- 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.
Philip Millar, PhD principal investigator
University of Guelph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beetroot drink in people with Diet, Healthy, 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 2 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 19 Sep 2024. 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 vascular conductance (time frame: Before intervention and 1, 2, 3 hours post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.