NCT06846840

Brief Summary

Infusion of beta-hydroxybutyrate can suppress endogenous glucose production, which may result in increased net liver glycogen storage. If ketone esters exert similar effects, then the increase in liver glycogen storage may have implication for recovery from exercise and subsequent exercise performance. The aim of this study is to assess the effects of ketone esters ingested during recovery from exercise, on metabolism and subsequent exercise capacity.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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

Study Start

First participant enrolled

November 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 26, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

February 26, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

February 20, 2025

Last Update Submit

February 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Glucose concentrations

    Blood glucose concentrations during the recovery period (240 minutes)

    240 minutes

Secondary Outcomes (2)

  • Non-oxidative fate of ingested sucrose

    240 minutes

  • Exercise capacity

    240 minutes

Other Outcomes (6)

  • Blood beta-hydroxybutyrate concentrations

    240 minutes

  • Urinary urea

    240 minutes

  • Blood lactate concentrations

    240 minutes

  • +3 more other outcomes

Study Arms (2)

PLACEBO

PLACEBO COMPARATOR

Energy matched placebo containing medium-chain triglycerides and bitter taste

Dietary Supplement: Placebo

KETONE

EXPERIMENTAL

Beta-hydroxybutyrate monoester

Dietary Supplement: Ketone ester

Interventions

Ketone esterDIETARY_SUPPLEMENT

0.29 g per kilogram body mass per hour of ketone monoester (R)-3-hydroxybutyrate (R)-3-hydroxybutyl

KETONE
PlaceboDIETARY_SUPPLEMENT

Medium chain triglycerides and bitter tastant (Bitrex)

PLACEBO

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • VO2max ≥ 45mL.kg-1.min-1
  • Weekly aerobic training \> 3hours.
  • years running experience.
  • BMI \< 30kg/m2

You may not qualify if:

  • \<18yrs or \>60yrs of age
  • Habitual smoker within last 5 years.
  • History of uncontrollable metabolic or respiratory disease.
  • Currently taking medication, following a low carbohydrate or ketogenic diet, or consuming nutritional ketone supplements.
  • History of Irritable Bowel Syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bath

Bath, Bath, BA2 7AY, United Kingdom

Location

MeSH Terms

Conditions

Motor Activity

Interventions

formic acid 4-(3-oxobutyl)phenyl ester

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nutrition and Metabolism

Study Record Dates

First Submitted

February 20, 2025

First Posted

February 26, 2025

Study Start

November 1, 2024

Primary Completion

February 17, 2025

Study Completion

May 1, 2025

Last Updated

February 26, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

Plan is to share individual deidentied data on a public repository such as Mendeleydata.

Locations