Exogenous Ketones and Glucose Tolerance

Phase 1

Completed

• Conditions: Ketones; Dietary Supplements
• Interventions: Dietary Supplement: Ketone monoester; Dietary Supplement: Placebo

• Registration Number: NCT03461068
• Lead Sponsor: University of British Columbia

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 an oral glucose tolerance test in individuals with impaired fasting glucose.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-04
• Study First Submitted QC: 2018-03-08
• Study First Posted: 2018-03-09
• Study Start: 2018-03-26
• Primary Completion: 2018-10-03
• Study Completion: 2018-10-15
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-17
• Last Update Posted: 2019-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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)

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ketone monoester	Ketone monoester	Acute morning dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.45 ml/kg body weight)
Placebo	Placebo	Acute morning dose of flavour-matched placebo.

Primary Outcome Measures

Name	Time	Method
Glucose area under the curve	2-hour	Area under the curve for glucose during oral glucose tolerance test

Secondary Outcome Measures

Name	Time	Method
Insulin incremental area under the curve	2-hour	Incremental area under the curve (above baseline) for insulin during oral glucose tolerance test
Free fatty acids area under the curve	2-hour	Non-esterified fatty acids area under the curve during oral glucose tolerance test
Insulin area under the curve	2-hour	Insulin area under the curve during oral glucose tolerance test
Inflammatory cytokines	15 minutes	Inflammatory cytokines assessed before and after ketone or placebo ingestion in the morning
C-peptide area under the curve	2-hour	C-peptide area under the curve during oral glucose tolerance test
GLP-1 area under the curve	2-hour	GLP-1 area under the curve during oral glucose tolerance test
Glucagon area under the curve	2-hour	Glucagon area under the curve during oral glucose tolerance test
Glucose incremental area under the curve	2-hour	Incremental area under the curve (above baseline) for glucose during oral glucose tolerance test
2-hr glucose level	2-hour	Plasma glucose assessed 2-hr after oral glucose tolerance test.
Caspase-1 activation	15 minutes	Caspase-1 activation assessed before and after ketone or placebo ingestion in the morning
Oral glucose sensitivity index	2-hour	Oral glucose sensitivity index derived from glucose and insulin values throughout the 2-hr oral glucose tolerance test

Trial Locations

Locations (1)

University of British Columbia, Okanagan.; 🇨🇦 Kelowna, British Columbia, Canada