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

Diet, Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06186050
• Other study ID #: 23-01-017
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2024
• Source: University of Guelph
• Contact: Philip Millar, PhD
• Phone: 5198244120
• Email: pmillar[@]uoguelph.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet, Healthy

Intervention

Dietary Supplement:
• Beetroot drink
Drink containing 10g of beetroot powder in 250 mL cold tap water
• Placebo
Mio flavouring in 250 mL cold tap water. Trace amounts of sugar and sodium were added to match the content in the beetroot supplement
• Control
Low-fat meal with cornflakes, greek yogurt, skim milk, and orange juice

Locations

Country	Name	City	State
Canada	University of Guelph - Human Cardiovascular Physiology Laboratory	Guelph	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Guelph

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forearm vascular conductance	Duplex ultrasound of brachial artery	Before intervention and 1, 2, 3 hours post-intervention
Primary	Forearm blood flow	Duplex ultrasound of brachial artery	Before intervention and 1, 2, 3 hours post-intervention
Primary	Systolic and Diastolic Blood Pressure	finger plethysmography	Before intervention and 1, 2, 3 hours post-intervention
Secondary	Plasma levels of Norepinephrine	ELISA kit	Blood collected before intervention and 1, 2, 3 hours post-intervention. Blood frozen at -80 degrees Celsius and analyzed at later date
Secondary	Plasma levels of Nitrate/Nitrite concentration	ELISA kit	Blood collected before intervention and 1, 2, 3 hours post-intervention. Blood frozen at -80 degrees Celsius and analyzed at later date
Secondary	Blood Glucose concentrations	Blood glucose monitor	Blood collected before intervention and 1, 2, 3 hours post-intervention. Blood analyzed immediately after collection at each time point
Secondary	Plasma levels of Triglycerides	Triglyceride assay kit	Blood collected before intervention and 1, 2, 3 hours post-intervention. Blood frozen at -80 degrees Celsius and analyzed at later date