The Effect of Ketone Esters on Forearm Glucose Metabolism
KAV
1 other identifier
interventional
14
1 country
1
Brief Summary
Ketones are naturally produced by our body and can affect our blood sugar levels. Ketones could be important tool for treating disease or recovering from exercise. The purpose of this research is to determine if a ketone drink can increase sugar uptake in our muscles. This research will provide new knowledge about the regulation of blood sugar.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Nov 2024
Typical duration for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2024
CompletedStudy Start
First participant enrolled
November 11, 2024
CompletedFirst Posted
Study publicly available on registry
November 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 28, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
ExpectedMay 8, 2026
May 1, 2026
1.2 years
November 11, 2024
May 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Forearm glucose net balance
Net balance of blood glucose across a forearm following a mixed meal tolerance test
3 hours
Secondary Outcomes (4)
Forearm non-esterified fatty acid net balance
3 hours
Forearm amino acid net balance
3 hours
Serum insulin concentrations
3 hours
Ketone concentration
3 hours
Study Arms (2)
Ketone supplementation
EXPERIMENTAL100 mL flavoured drink containing 0.3 g/kg ketone monoester ((R)-3-hydroxybutyl (R)-3-hydroxybutyrate; ΔG®, University of Oxford; https://www.deltagketones.com)
Placebo
PLACEBO COMPARATORPlacebo with bitter agent to flavour match
Interventions
100 mL flavoured drink containing 0.3 g/kg ketone monoester ((R)-3-hydroxybutyl (R)-3-hydroxybutyrate; ΔG®, University of Oxford; https://www.deltagketones.com) consumed 30 min prior to a mixed meal tolerance test
Placebo with bitter agent to flavour match, consumed 30 min prior to a mixed meal tolerance test
Eligibility Criteria
You may qualify if:
- Age 18-40
You may not qualify if:
- Any diagnosed metabolic health condition
- Pregnant
- Smoker
- Diagnosed Cardiovascular disease
- Use of medications deemed by research team to affect study outcomes
- Recent history of musculoskeletal injury
- Aged \>40 or \<18
- Allergy to ingredients in the supplement, including ketones, lactose or milk protein
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nutritional Physiology Research Unit, University of Exeter
Exeter, Devon, EX1 2LU, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
George F Pavis, PhD
University of Exeter
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Coded, known only to one independent individual
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2024
First Posted
November 13, 2024
Study Start
November 11, 2024
Primary Completion
January 28, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
May 8, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
Anonymised data will be made available on open access public repositories