The Effect of Ketone Esters on Forearm Glucose Metabolism (KAV)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Ketone supplement; Dietary supplement: Placebo supplement

Detailed Description

Impaired skeletal muscle glucose uptake following a meal ("insulin resistance"), is a primary risk factor for developing type 2 diabetes. We and others have consistently shown that ingesting exogenous ketones can reduce blood glucose concentration. Mechanistically, this must arise through reduced glucose release (i.e. from liver), and/or increased uptake (i.e. into skeletal muscle). Our current MRC-funded work is focussing on ketone-liver interactions in patients with type 2 diabetes. Here we aim to investigate how KE influence skeletal muscle glucose metabolism.

• Study Type: Interventional
• Enrollment (Estimated): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Devon
    • Exeter, Devon, United Kingdom, EX1 2LU
      • Nutritional Physiology Research Unit, University of Exeter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 18-40

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ketone supplementation; 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)	Dietary supplement: Ketone supplement; 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 Comparator: Placebo; Placebo with bitter agent to flavour match	Dietary supplement: Placebo supplement; Placebo with bitter agent to flavour match, consumed 30 min prior to a mixed meal tolerance test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forearm glucose net balance	Net balance of blood glucose across a forearm following a mixed meal tolerance test	3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forearm non-esterified fatty acid net balance	Net balance of blood non-esterified fatty acids across a forearm after a mixed meal tolerance test	3 hours
Forearm amino acid net balance	Net balance of blood amino acids across a forearm following a mixed meal tolerance test	3 hours
Serum insulin concentrations	Insulin concentration using ELISA assay over 4 and 8 hours following a meal	3 hours
Ketone concentration	Ketone concentration using colorimetric assay over 4 and 8 hours following a meal	3 hours

Collaborators and Investigators

• Sponsor: University of Exeter
• Investigators: Principal Investigator: George F Pavis, PhD, University of Exeter

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2024
• Primary Completion (Actual): January 28, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: November 11, 2024
• First Submitted That Met QC Criteria: November 11, 2024
• First Posted (Actual): November 13, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Substrate metabolism; Blood glucose; Ketone monoester
• Other Study ID Numbers: 5390017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymised data will be made available on open access public repositories
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No