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The Effects of Exogenous Ketones on Glucose Tolerance

University of British Columbia logo

University of British Columbia

Status and phase

Completed
Phase 1

Conditions

Dietary Supplement: Ketone Supplement
Dietary Supplement: Placebo

Treatments

Dietary Supplement: Ketone monoester
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT04088617
H16-01846-B

Details and patient eligibility

About

The ketone body beta-hydroxybutyrate is produced during prolonged fasting or when endogenous carbohydrate stores are depleted and can be used as an alternative fuel source. Exogenous beta-hydroxybutyrate, in the form of a ketone monoester, is proposed to have glucose-lowering potential but this has not been adequately studied. The purpose of this study is to determine whether supplementing with an acute dose of ketone monoester can improve the glycemic response to a high carbohydrate mixed meal in young healthy individuals.

Enrollment

20 patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Young healthy individuals
  • Not taking any medications affecting glucose metabolism

Exclusion criteria

  • Competitive endurance athlete (i.e., train specifically for cycling, triathlon or distance running and compete at a high level)
  • Diagnosed with the chronic medical condition that may impact consumption of carbohydrates or supplements (e.g., diabetes, heart disease)
  • Are currently using medications that may interfere with insulin sensitivity
  • Adhere to a strict high-fat low-carbohydrate or ketogenic diet (within the last 3 months)
  • Are currently using ketone supplements
  • Unable to travel to and from the university in order to make your testing appointments.
  • Unable to follow the controlled diet instructions required for the study.
  • If pregnant or are planning to become pregnant during the study (if female)

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

20 participants in 2 patient groups, including a placebo group

Ketone monoester
Experimental group
Description:
Acute morning dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.45 ml/kg body weight)
Treatment:
Dietary Supplement: Ketone monoester
Placebo
Placebo Comparator group
Description:
Acute morning dose of flavour-matched placebo.
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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