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

NCT04881526 | Completed

• 1 other identifier: 21-02-019
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Ketosis

Outcome Measures

Primary Outcomes (4)

• Muscle sympathetic nerve activity

  Microneurography of fibular nerve

  Baseline - Immediately before active and control interventions

• Muscle sympathetic nerve activity

  Microneurography of fibular nerve

  Post-intervention - Immediately following active and control interventions

• Blood pressure

  Finger plethysmography

  Baseline - Immediately before active and control interventions

• Blood pressure

  Finger plethysmography

  Post-intervention - Immediately following active and control interventions

Secondary Outcomes (2)

• Forearm blood flow

  Baseline - Immediately before active and control interventions

• Forearm blood flow

  Post-intervention - Immediately following active and control interventions

Study Arms (2)

Ketone ester drink

ACTIVE COMPARATOR

Dietary Supplement: D-beta-hydroxybutyrate

Placebo drink

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

D-beta-hydroxybutyrate DIETARY_SUPPLEMENT

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

Ketone ester drink

Placebo DIETARY_SUPPLEMENT

Isocaloric flavored water with medium-chain triglyceride oil.

Placebo drink

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Guelph: lead

Study Sites (1)

University of Guelph - Human Cardiovascular Physiology Laboratory

Guelph, Ontario, N1G2W1, Canada

Location

MeSH Terms

Conditions

Ketosis

Condition Hierarchy (Ancestors)

Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

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, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 11, 2021
• Study Start: June 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)