The Effect of Ketone Esters on Forearm Glucose Metabolism

NCT06685913 | Recruiting

• 1 other identifier: 5390017
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 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.

Conditions

Healthy

Keywords

Blood glucose; Ketone monoester; Substrate metabolism

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

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Placebo with bitter agent to flavour match

Dietary Supplement: Placebo supplement

Interventions

Ketone supplement 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

Ketone supplementation

Placebo supplement DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• University of Exeter: lead

Study Sites (1)

Nutritional Physiology Research Unit, University of Exeter

Exeter, Devon, EX1 2LU, United Kingdom

RECRUITING

Study Officials

• George F Pavis, PhD

  University of Exeter

  PRINCIPAL INVESTIGATOR

Central Study Contacts

George F Pavis, PhD

CONTACT

+44 01392 725906; g.pavis@exeter.ac.uk

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: December 31, 2025
• Study Completion (Estimated): December 31, 2034
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

GB (1)