NCT06186050

Brief 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. 1.What are the mechanisms responsible for reduced exercise-mediated sympatholysis following a high-fat meal
  2. 2.Can dietary nitrate prevent the declines in exercise-mediated sympatholysis
  3. 3.Low-fat meal
  4. 4.High-fat meal
  5. 5.High-fat meal plus dietary nitrate

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

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

December 15, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 29, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

January 8, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

7 months

First QC Date

December 15, 2023

Last Update Submit

September 16, 2024

Conditions

Diet, Healthy

Keywords

Functional sympatholysisExercise

Outcome Measures

Primary Outcomes (3)

  • Forearm vascular conductance

    Duplex ultrasound of brachial artery

    Before intervention and 1, 2, 3 hours post-intervention

  • Forearm blood flow

    Duplex ultrasound of brachial artery

    Before intervention and 1, 2, 3 hours post-intervention

  • Systolic and Diastolic Blood Pressure

    finger plethysmography

    Before intervention and 1, 2, 3 hours post-intervention

Secondary Outcomes (4)

  • Plasma levels of Norepinephrine

    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

    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 collected before intervention and 1, 2, 3 hours post-intervention. Blood analyzed immediately after collection at each time point

  • Plasma levels of Triglycerides

    Blood collected before intervention and 1, 2, 3 hours post-intervention. Blood frozen at -80 degrees Celsius and analyzed at later date

Study Arms (3)

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

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

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

Dietary Supplement: Control

Interventions

Beetroot drinkDIETARY_SUPPLEMENT

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

Also known as: Superbeets
High-fat meal with Beetroot Drink
PlaceboDIETARY_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

Also known as: Mio
High-fat meal with Placebo Drink
ControlDIETARY_SUPPLEMENT

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

Low-fat meal control

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Guelph - Human Cardiovascular Physiology Laboratory

Guelph, Ontario, N1G2W1, Canada

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Philip Millar, PhD

    University of Guelph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 15, 2023

First Posted

December 29, 2023

Study Start

January 8, 2024

Primary Completion

July 30, 2024

Study Completion

July 30, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)