Ketone Ester Supplementation on Neuro-cardiovascular Responses to Stress in Humans
Primary Purpose
Ketosis
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
D-beta-hydroxybutyrate
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Ketosis
Eligibility Criteria
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.
Sites / Locations
- University of Guelph - Human Cardiovascular Physiology Laboratory
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ketone ester drink
Placebo drink
Arm Description
Outcomes
Primary Outcome Measures
Muscle sympathetic nerve activity
Microneurography of fibular nerve
Muscle sympathetic nerve activity
Microneurography of fibular nerve
Blood pressure
Finger plethysmography
Blood pressure
Finger plethysmography
Secondary Outcome Measures
Forearm blood flow
Brachial artery Doppler ultrasound
Forearm blood flow
Brachial artery Doppler ultrasound
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04881526
Brief Title
Ketone Ester Supplementation on Neuro-cardiovascular Responses to Stress in Humans
Official Title
Ketone Ester Supplementation on Neuro-cardiovascular Responses to Stress in Humans
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guelph
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ketosis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Masking Description
Double-blind
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ketone ester drink
Arm Type
Active Comparator
Arm Title
Placebo drink
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
D-beta-hydroxybutyrate
Intervention Description
Drink containing D-beta-hydroxybutyrate administered at a dose of 395 mg/kg.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Isocaloric flavored water with medium-chain triglyceride oil.
Primary Outcome Measure Information:
Title
Muscle sympathetic nerve activity
Description
Microneurography of fibular nerve
Time Frame
Baseline - Immediately before active and control interventions
Title
Muscle sympathetic nerve activity
Description
Microneurography of fibular nerve
Time Frame
Post-intervention - Immediately following active and control interventions
Title
Blood pressure
Description
Finger plethysmography
Time Frame
Baseline - Immediately before active and control interventions
Title
Blood pressure
Description
Finger plethysmography
Time Frame
Post-intervention - Immediately following active and control interventions
Secondary Outcome Measure Information:
Title
Forearm blood flow
Description
Brachial artery Doppler ultrasound
Time Frame
Baseline - Immediately before active and control interventions
Title
Forearm blood flow
Description
Brachial artery Doppler ultrasound
Time Frame
Post-intervention - Immediately following active and control interventions
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Millar, PhD
Organizational Affiliation
University of Guelph
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Guelph - Human Cardiovascular Physiology Laboratory
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1G2W1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ketone Ester Supplementation on Neuro-cardiovascular Responses to Stress in Humans
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