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Clinical Trials/NCT06685913
NCT06685913Active, not recruitingNot Applicable

The Effect of Ketone Esters on Forearm Glucose Metabolism

University of Exeter2 sites in 1 country14 target enrollmentStarted: November 11, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
14
Locations
2
Primary Endpoint
Forearm glucose net balance

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description

Coded, known only to one independent individual

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Age 18-40

Exclusion Criteria

  • Any diagnosed metabolic health condition
  • 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

Arms & Interventions

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)

Intervention: Ketone supplement (Dietary Supplement)

Placebo

Placebo Comparator

Placebo with bitter agent to flavour match

Intervention: Placebo supplement (Dietary Supplement)

Outcomes

Primary Outcomes

Forearm glucose net balance

Time Frame: 3 hours

Net balance of blood glucose across a forearm following a mixed meal tolerance test

Secondary Outcomes

  • Forearm amino acid net balance(3 hours)
  • Serum insulin concentrations(3 hours)
  • Ketone concentration(3 hours)
  • Forearm non-esterified fatty acid net balance(3 hours)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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