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Completed

NCT Number: NCT03461068

Exogenous Ketones and Glucose Tolerance

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.

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Key information

Conditions

Ketones Acid-Base Imbalance Acidosis Dietary Supplements Ketosis Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of British Columbia, Okanagan.

Kelowna, British Columbia, V1V 1V7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ketone monoester

Dietary Supplement

Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior a 2-hour oral glucose tolerance test.

Placebo

Dietary Supplement

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

Primary outcomes

  1. Glucose area under the curve

    Time frame: 2-hour

    Area under the curve for glucose during oral glucose tolerance test

Secondary outcomes

  1. Insulin area under the curve

    Time frame: 2-hour

    Insulin area under the curve during oral glucose tolerance test

  2. Free fatty acids area under the curve

    Time frame: 2-hour

    Non-esterified fatty acids area under the curve during oral glucose tolerance test

  3. Caspase-1 activation

    Time frame: 15 minutes

    Caspase-1 activation assessed before and after ketone or placebo ingestion in the morning

  4. Inflammatory cytokines

    Time frame: 15 minutes

    Inflammatory cytokines assessed before and after ketone or placebo ingestion in the morning

  5. C-peptide area under the curve

    Time frame: 2-hour

    C-peptide area under the curve during oral glucose tolerance test

  6. GLP-1 area under the curve

    Time frame: 2-hour

    GLP-1 area under the curve during oral glucose tolerance test

  7. Glucagon area under the curve

    Time frame: 2-hour

    Glucagon area under the curve during oral glucose tolerance test

  8. Glucose incremental area under the curve

    Time frame: 2-hour

    Incremental area under the curve (above baseline) for glucose during oral glucose tolerance test

  9. Insulin incremental area under the curve

    Time frame: 2-hour

    Incremental area under the curve (above baseline) for insulin during oral glucose tolerance test

  10. 2-hr glucose level

    Time frame: 2-hour

    Plasma glucose assessed 2-hr after oral glucose tolerance test.

  11. Oral glucose sensitivity index

    Time frame: 2-hour

    Oral glucose sensitivity index derived from glucose and insulin values throughout the 2-hr oral glucose tolerance test

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 9, 2018
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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