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Exogenous Ketones and Glucose Tolerance

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University of British Columbia

Status and phase

Completed
Phase 1

Conditions

Ketones
Dietary Supplements

Treatments

Dietary Supplement: Ketone monoester
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03461068
H16-01846

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

30 to 65 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

15 participants in 2 patient groups, including a placebo group

Ketone monoester
Experimental group
Description:
Acute morning dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.45 ml/kg body weight)
Treatment:
Dietary Supplement: Ketone monoester
Placebo
Placebo Comparator group
Description:
Acute morning dose of flavour-matched placebo.
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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