The Effect of Ketone Esters on Forearm Glucose Metabolism

NCT ID: NCT06685913

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-11
• Study Completion Date: 2034-12-31

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.

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

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)

Group Type: EXPERIMENTAL

Ketone supplement

Intervention Type: DIETARY_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

Placebo with bitter agent to flavour match

Group Type: PLACEBO_COMPARATOR

Placebo supplement

Intervention Type: DIETARY_SUPPLEMENT

Placebo with bitter agent to flavour match, consumed 30 min prior to a mixed meal tolerance test

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo supplement

Placebo with bitter agent to flavour match, consumed 30 min prior to a mixed meal tolerance test

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Exeter

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George F Pavis, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Exeter

Locations

Nutritional Physiology Research Unit, University of Exeter

Exeter, Devon, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

George F Pavis, PhD

Role: CONTACT

g.pavis@exeter.ac.uk

+44 01392 725906

Facility Contacts

George F Pavis, PhD

Role: primary

g.pavis@exeter.ac.uk

+44 01392 725906

Other Identifiers

5390017

Identifier Type: -

Identifier Source: org_study_id