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

Sponsor
University of Guelph (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04881526
Collaborator
(none)
17
Enrollment
1
Location
2
Arms
16
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: D-beta-hydroxybutyrate
  • Dietary Supplement: Placebo
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
Double-blind
Primary Purpose:
Basic Science
Official Title:
Ketone Ester Supplementation on Neuro-cardiovascular Responses to Stress in Humans
Actual Study Start Date :
Jun 1, 2021
Actual Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Ketone ester drink

Dietary Supplement: D-beta-hydroxybutyrate
Drink containing D-beta-hydroxybutyrate administered at a dose of 395 mg/kg.
Placebo Comparator: Placebo drink

Dietary Supplement: Placebo
Isocaloric flavored water with medium-chain triglyceride oil.

Outcome Measures

Primary Outcome Measures

  1. Muscle sympathetic nerve activity [Baseline - Immediately before active and control interventions]

    Microneurography of fibular nerve

  2. Muscle sympathetic nerve activity [Post-intervention - Immediately following active and control interventions]

    Microneurography of fibular nerve

  3. Blood pressure [Baseline - Immediately before active and control interventions]

    Finger plethysmography

  4. Blood pressure [Post-intervention - Immediately following active and control interventions]

    Finger plethysmography

Secondary Outcome Measures

  1. Forearm blood flow [Baseline - Immediately before active and control interventions]

    Brachial artery Doppler ultrasound

  2. Forearm blood flow [Post-intervention - Immediately following active and control interventions]

    Brachial artery Doppler ultrasound

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Guelph - Human Cardiovascular Physiology Laboratory Guelph Ontario Canada N1G2W1

Sponsors and Collaborators

  • University of Guelph

Investigators

  • Principal Investigator: Philip Millar, PhD, University of Guelph

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Philip Millar, Associate Professor, University of Guelph
ClinicalTrials.gov Identifier:
NCT04881526
Other Study ID Numbers:
  • 21-02-019
First Posted:
May 11, 2021
Last Update Posted:
Jun 15, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Ketosis

Study Results

No Results Posted as of Jun 15, 2022