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The Effects of Exogenous Ketones on Glucose Tolerance

The Effects of Exogenous Ketones on Glucose Tolerance

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04088617
Enrollment
20
Registered
2019-09-13
Start date
2019-08-01
Completion date
2020-01-05
Last updated
2020-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dietary Supplement: Ketone Supplement, Dietary Supplement: Placebo

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTKetone monoester

Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior a 2-hour high carbohydrate mixed meal tolerance test.

DIETARY_SUPPLEMENTPlacebo

Acute ingestion of a taste-matched placebo prior a 2-hour high carbohydrate mixed meal tolerance test.

Sponsors

University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Placebo masked with flavouring and participants consume in opaque containers

Intervention model description

Crossover assignment

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Glucose area under the curve2-hourArea under the curve for glucose during high carbohydrate mixed meal tolerance test

Secondary

MeasureTime frameDescription
Free fatty acids area under the curve2-hourNon-esterified fatty acids area under the curve during high carbohydrate mixed meal tolerance test
Glucose incremental area under the curve2-hourIncremental area under the curve (above baseline) for glucose during high carbohydrate mixed meal tolerance test
Insulin area under the curve2-hourInsulin area under the curve during high carbohydrate mixed meal tolerance test
2-hr glucose level2-hourPlasma glucose assessed 2-hr after high carbohydrate mixed meal tolerance test
Beta-hydroxybutyrate level2-hourBlood beta-hydroxybutyrate concentration assessed by handheld monitor
Insulin incremental area under the curve2-hourIncremental area under the curve (above baseline) for insulin during high carbohydrate mixed meal tolerance test

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026