NCT06685913

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

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable healthy

Timeline
1mo left

Started Nov 2024

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Nov 2024Sep 2026

First Submitted

Initial submission to the registry

November 11, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

November 11, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2026

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

1.2 years

First QC Date

November 11, 2024

Last Update Submit

May 5, 2026

Conditions

Keywords

Blood glucoseKetone monoesterSubstrate 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 supplementDIETARY_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 supplementDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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

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

Location

Study Officials

  • George F Pavis, PhD

    University of Exeter

    PRINCIPAL INVESTIGATOR

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

Anonymised data will be made available on open access public repositories

Shared Documents
STUDY PROTOCOL, SAP, CSR

Locations