The Effects of Exogenous Ketones on Glucose Tolerance

Dietary Supplement: Ketone Supplement Clinical Trial

Official title:

The Effects of Exogenous Ketones on Glucose Tolerance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04088617
• Other study ID #: H16-01846-B
• Status: Completed
• Phase: Phase 1
• Start date: August 1, 2019
• Est. completion date: January 5, 2020

Study information

• Verified date: March 2020
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 5, 2020
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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)

Related Conditions & MeSH terms

• Dietary Supplement: Ketone Supplement
• Dietary Supplement: Placebo

Intervention

Dietary Supplement:
• Ketone monoester
Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior a 2-hour high carbohydrate mixed meal tolerance test.
• Placebo
Acute ingestion of a taste-matched placebo prior a 2-hour high carbohydrate mixed meal tolerance test.

Locations

Country	Name	City	State
Canada	University of British Columbia, Okanagan	Kelowna	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose area under the curve	Area under the curve for glucose during high carbohydrate mixed meal tolerance test	2-hour
Secondary	Insulin area under the curve	Insulin area under the curve during high carbohydrate mixed meal tolerance test	2-hour
Secondary	Free fatty acids area under the curve	Non-esterified fatty acids area under the curve during high carbohydrate mixed meal tolerance test	2-hour
Secondary	Glucose incremental area under the curve	Incremental area under the curve (above baseline) for glucose during high carbohydrate mixed meal tolerance test	2-hour
Secondary	Insulin incremental area under the curve	Incremental area under the curve (above baseline) for insulin during high carbohydrate mixed meal tolerance test	2-hour
Secondary	2-hr glucose level	Plasma glucose assessed 2-hr after high carbohydrate mixed meal tolerance test	2-hour
Secondary	Beta-hydroxybutyrate level	Blood beta-hydroxybutyrate concentration assessed by handheld monitor	2-hour