Exogenous Ketones and Glucose Tolerance

NCT03461068 | Completed Phase 1

• 1 other identifier: H16-01846
• Study Type: interventional
• Target: 15
• 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 an oral glucose tolerance test in individuals with impaired fasting glucose.

Conditions

Ketones; Dietary Supplements

Outcome Measures

Primary Outcomes (1)

• Glucose area under the curve

  Area under the curve for glucose during oral glucose tolerance test

  2-hour

Secondary Outcomes (11)

• Insulin area under the curve

  2-hour

• Free fatty acids area under the curve

  2-hour

• Caspase-1 activation

  15 minutes

• Inflammatory cytokines

  15 minutes

• C-peptide area under the curve

  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 oral glucose tolerance test.

Ketone monoester

Placebo DIETARY_SUPPLEMENT

Acute ingestion of a taste-matched placebo prior a 2-hour oral glucose tolerance test.

Placebo

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia, Okanagan.

Kelowna, British Columbia, V1V 1V7, Canada

Location

Related Publications (1)

• Myette-Cote E, Caldwell HG, Ainslie PN, Clarke K, Little JP. A ketone monoester drink reduces the glycemic response to an oral glucose challenge in individuals with obesity: a randomized trial. Am J Clin Nutr. 2019 Dec 1;110(6):1491-1501. doi: 10.1093/ajcn/nqz232.

  PMID: 31599919 DERIVED

MeSH Terms

Conditions

Ketosis

Condition Hierarchy (Ancestors)

Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

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: Assistant Professor

Study Record Dates

• First Submitted: March 4, 2018
• First Posted: March 9, 2018
• Study Start: March 26, 2018
• Primary Completion: October 3, 2018
• Study Completion: October 15, 2018
• Last Updated: April 18, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)