Exogenous Ketones and Glucose Tolerance

Dietary Supplements Clinical Trial

Official title:

The Effect of Exogenous Ketone Monoester Supplement on Glycemic Response to an Oral Glucose Tolerance Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03461068
• Other study ID #: H16-01846
• Status: Completed
• Phase: Phase 1
• Start date: March 26, 2018
• Est. completion date: October 15, 2018

Study information

• Verified date: April 2019
• 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 an oral glucose tolerance test in individuals with impaired fasting glucose.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 15, 2018
• Est. primary completion date: October 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• Not taking any medications affecting glucose metabolism.

• Elevated fasting glucose level (5.6-6.9 mmol/L) OR body mass index >28 kg/m2 OR elevated waist circumference (>102 cm for males, >88 cm for females)

Exclusion Criteria:

• Diagnosed with diabetes.

• Diagnosed with heart disease.

• Competitive endurance athlete (self-identified as engaged in specific endurance training in triathlon, cycling, or distance running and competing in races or competition)

• Recent (last 3 months) or current consumption of a low-carbohydrate ketogenic diet

• Current consumption of ketone supplements

• Pregnant or planning to become pregnant during the study (if female)

Related Conditions & MeSH terms

• Dietary Supplements
• Ketones

Intervention

Dietary Supplement:
• Ketone monoester
Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior a 2-hour oral glucose tolerance test.
• Placebo
Acute ingestion of a taste-matched placebo prior a 2-hour oral glucose 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 oral glucose tolerance test	2-hour
Secondary	Insulin area under the curve	Insulin area under the curve during oral glucose tolerance test	2-hour
Secondary	Free fatty acids area under the curve	Non-esterified fatty acids area under the curve during oral glucose tolerance test	2-hour
Secondary	Caspase-1 activation	Caspase-1 activation assessed before and after ketone or placebo ingestion in the morning	15 minutes
Secondary	Inflammatory cytokines	Inflammatory cytokines assessed before and after ketone or placebo ingestion in the morning	15 minutes
Secondary	C-peptide area under the curve	C-peptide area under the curve during oral glucose tolerance test	2-hour
Secondary	GLP-1 area under the curve	GLP-1 area under the curve during oral glucose tolerance test	2-hour
Secondary	Glucagon area under the curve	Glucagon area under the curve during oral glucose tolerance test	2-hour
Secondary	Glucose incremental area under the curve	Incremental area under the curve (above baseline) for glucose during oral glucose tolerance test	2-hour
Secondary	Insulin incremental area under the curve	Incremental area under the curve (above baseline) for insulin during oral glucose tolerance test	2-hour
Secondary	2-hr glucose level	Plasma glucose assessed 2-hr after oral glucose tolerance test.	2-hour
Secondary	Oral glucose sensitivity index	Oral glucose sensitivity index derived from glucose and insulin values throughout the 2-hr oral glucose tolerance test	2-hour