The Effects of Exogenous Ketones on Glucose Tolerance

NCT04088617 | Completed Phase 1

• 1 other identifier: H16-01846-B
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Dietary Supplement: Ketone Supplement; Dietary Supplement: Placebo

Outcome Measures

Primary Outcomes (1)

• Glucose area under the curve

  Area under the curve for glucose during high carbohydrate mixed meal tolerance test

  2-hour

Secondary Outcomes (6)

• Insulin area under the curve

  2-hour

• Free fatty acids area under the curve

  2-hour

• Glucose incremental area under the curve

  2-hour

• Insulin incremental area under the curve

  2-hour

• 2-hr glucose level

  2-hour

Study Arms (2)

Ketone monoester

EXPERIMENTAL

Acute morning dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.45 ml/kg body weight)

Dietary Supplement: Ketone monoester

Placebo

PLACEBO COMPARATOR

Acute morning dose of flavour-matched placebo.

Dietary Supplement: Placebo

Interventions

Ketone monoester DIETARY_SUPPLEMENT

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

Ketone monoester

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia, Okanagan

Kelowna, British Columbia, V1V 1V7, Canada

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Placebo masked with flavouring and participants consume in opaque containers
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Crossover assignment

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 13, 2019
• Study Start: August 1, 2019
• Primary Completion: October 30, 2019
• Study Completion: January 5, 2020
• Last Updated: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)