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Completed

NCT Number: NCT04881526

Ketone Ester Supplementation on Neuro-cardiovascular Responses to Stress in Humans

Ketone ester supplementation has become increasingly popular as an athletic supplement. However, the metabolic effects of these supplements on exercise performance are controversial. One potential reason for lack of an ergogenic benefit could be the effects of ketone bodies on other bodily systems, such as the sympathetic nervous system. During exercise and stress the body increases the activity of the sympathetic nervous system. This causes blood vessels to constrict (get smaller) and can increase blood pressure. Studies have shown that ketone bodies can suppress the sympathetic nervous system in mice. Additionally, ketone ester supplementation can reduce blood pressure in healthy adults. In humans, direct measures of sympathetic activity are usually made from sympathetic outflow to muscle, also called muscle sympathetic nerve activity (MSNA). Using a ketone ester supplement, the investigators plan to measure blood pressure and sympathetic outflow to muscle at rest and during handgrip exercise and a mathematical task stress test to investigate the effect of ketones on neuro-cardiovascular stress responses.

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Key information

Age range

18 year–40 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 to 40 years of age
  • Healthy, free of known cardiovascular, metabolic, or musculoskeletal disease

Exclusion criteria

  • History of smoking (within 3 months), diagnosed cardiovascular or metabolic disease, recent musculoskeletal injury preventing handgrip exercise, prescription of chronic medications other than oral contraceptives.
  • Current or recent (within 6 months) use of ketone ester supplementation or participation in a ketogenic diet.
  • Inability to abstain from drugs, caffeine, alcohol, or strenuous physical activity prior to the study visit.

Treatment and study plan

D-beta-hydroxybutyrate

Dietary Supplement

Drink containing D-beta-hydroxybutyrate administered at a dose of 395 mg/kg.

Placebo

Dietary Supplement

Isocaloric flavored water with medium-chain triglyceride oil.

Primary outcomes

  1. Muscle sympathetic nerve activity

    Time frame: Baseline - Immediately before active and control interventions

    Microneurography of fibular nerve

  2. Muscle sympathetic nerve activity

    Time frame: Post-intervention - Immediately following active and control interventions

    Microneurography of fibular nerve

  3. Blood pressure

    Time frame: Baseline - Immediately before active and control interventions

    Finger plethysmography

  4. Blood pressure

    Time frame: Post-intervention - Immediately following active and control interventions

    Finger plethysmography

Secondary outcomes

  1. Forearm blood flow

    Time frame: Baseline - Immediately before active and control interventions

    Brachial artery Doppler ultrasound

  2. Forearm blood flow

    Time frame: Post-intervention - Immediately following active and control interventions

    Brachial artery Doppler ultrasound

Sponsors and collaborators

Lead sponsor

University of Guelph

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 11, 2021
Registry last updated
Sep 22, 2023

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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