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

Ketosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04881526
• Other study ID #: 21-02-019
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: September 2023
• Source: University of Guelph
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ketosis

Intervention

Dietary Supplement:
• D-beta-hydroxybutyrate
Drink containing D-beta-hydroxybutyrate administered at a dose of 395 mg/kg.
• Placebo
Isocaloric flavored water with medium-chain triglyceride oil.

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	Muscle sympathetic nerve activity	Microneurography of fibular nerve	Baseline - Immediately before active and control interventions
Primary	Muscle sympathetic nerve activity	Microneurography of fibular nerve	Post-intervention - Immediately following active and control interventions
Primary	Blood pressure	Finger plethysmography	Baseline - Immediately before active and control interventions
Primary	Blood pressure	Finger plethysmography	Post-intervention - Immediately following active and control interventions
Secondary	Forearm blood flow	Brachial artery Doppler ultrasound	Baseline - Immediately before active and control interventions
Secondary	Forearm blood flow	Brachial artery Doppler ultrasound	Post-intervention - Immediately following active and control interventions