NCT07063732

Brief Summary

The purpose of this trial is to investigate the effect of acute ketone monoester ingestion (0.6 g KME/kg body weight) on the occurrence of the ventilatory threshold and the subsequent response of blood velocity in cerebral arteries during a maximal exercise test at low altitude and high altitude.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

May 28, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

May 28, 2025

Last Update Submit

July 2, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cerebral Blood Velocity

    Transcranial Doppler ultrasound will be used to measure blood velocity in the middle cerebral artery and posterior cerebral artery. Location of measurements will remain consistent within participants.

    3 hours

Secondary Outcomes (8)

  • Cardiac Output

    3 hours

  • Blood Pressure

    3 hours

  • Ventilatory Threshold

    3 hours

  • End-Tidal Gases

    3 hours

  • Rate of Oxygen Consumption and Carbon Dioxide Production

    3 hours

  • +3 more secondary outcomes

Study Arms (2)

High Altitude (3800m; Barcroft Research Station)

EXPERIMENTAL

High altitude setting

Dietary Supplement: Ketone Monoester (KME)Dietary Supplement: Placebo

Low Altitude (334m; University of Guelph)

EXPERIMENTAL

Low altitude setting

Dietary Supplement: Ketone Monoester (KME)Dietary Supplement: Placebo

Interventions

Ketone Monoester (KME)DIETARY_SUPPLEMENT

0.6 g KME per kg body mass; \[R\]-3-hydroxybutyl \[R\]-3-hydroxybutyrate. (Delta G Ketone, TΔS, Oxford).

High Altitude (3800m; Barcroft Research Station)Low Altitude (334m; University of Guelph)
PlaceboDIETARY_SUPPLEMENT

Inert, calorie-free placebo drink that is taste-matched to the ketone monoester supplement

High Altitude (3800m; Barcroft Research Station)Low Altitude (334m; University of Guelph)

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Must be a member of the research expedition team travelling to the Barcroft Research Station in White Mountain California

You may not qualify if:

  • BMI \> 30
  • No prescribed medications (oral contraceptives excluded)
  • History of smoking
  • Currently following a ketogenic diet or consuming exogenous ketogenic supplements
  • History of heart, lung, blood vessel, or kidney disease
  • Currently pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Barcroft Research Station

Bishop, California, 93514, United States

RECRUITING

University of Guelph

Guelph, Ontario, N1G 2W1, Canada

RECRUITING

Related Publications (1)

  • Gaskill SE, Ruby BC, Walker AJ, Sanchez OA, Serfass RC, Leon AS. Validity and reliability of combining three methods to determine ventilatory threshold. Med Sci Sports Exerc. 2001 Nov;33(11):1841-8. doi: 10.1097/00005768-200111000-00007.

    PMID: 11689733BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 28, 2025

First Posted

July 14, 2025

Study Start

May 28, 2025

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

July 14, 2025

Record last verified: 2025-07

Locations