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Completed

NCT Number: NCT06186050

Effects of a High-fat Meal on Exercise-mediated Sympatholysis

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. Can dietary nitrate prevent the declines in exercise-mediated sympatholysis

Participants will be asked to complete three study visits in a randomized order:

1. Low-fat meal 2. High-fat meal 3. 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.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Guelph - Human Cardiovascular Physiology Laboratory

Guelph, Ontario, N1G2W1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-30 years of age
  • Healthy, free of known cardiovascular, metabolic, or musculoskeletal disease

Exclusion criteria

  • 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

Treatment and study plan

Beetroot drink

Dietary Supplement

Drink containing 10g of beetroot powder in 250 mL cold tap water

Other names: Superbeets

Placebo

Dietary Supplement

Mio flavouring in 250 mL cold tap water. Trace amounts of sugar and sodium were added to match the content in the beetroot supplement

Other names: Mio

Control

Dietary Supplement

Low-fat meal with cornflakes, greek yogurt, skim milk, and orange juice

Primary outcomes

  1. Forearm vascular conductance

    Time frame: Before intervention and 1, 2, 3 hours post-intervention

    Duplex ultrasound of brachial artery

  2. Forearm blood flow

    Time frame: Before intervention and 1, 2, 3 hours post-intervention

    Duplex ultrasound of brachial artery

  3. Systolic and Diastolic Blood Pressure

    Time frame: Before intervention and 1, 2, 3 hours post-intervention

    finger plethysmography

Secondary outcomes

  1. 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

    ELISA kit

  2. 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

    ELISA kit

  3. 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

    Blood glucose monitor

  4. 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

    Triglyceride assay kit

Sponsors and collaborators

Lead sponsor

University of Guelph

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 29, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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