Ketones, Dietary Supplements
Conditions
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.
Interventions
DIETARY_SUPPLEMENTKetone monoester
Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior a 2-hour oral glucose tolerance test.
DIETARY_SUPPLEMENTPlacebo
Acute ingestion of a taste-matched placebo prior a 2-hour oral glucose tolerance test.
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Placebo masked with flavouring and participants consume in opaque containers
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose area under the curve | 2-hour | Area under the curve for glucose during oral glucose tolerance test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Free fatty acids area under the curve | 2-hour | Non-esterified fatty acids area under the curve during oral glucose tolerance test |
| Caspase-1 activation | 15 minutes | Caspase-1 activation assessed before and after ketone or placebo ingestion in the morning |
| 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 |
| Insulin area under the curve | 2-hour | Insulin 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 |
| Insulin incremental area under the curve | 2-hour | Incremental area under the curve (above baseline) for insulin during oral glucose tolerance test |
| 2-hr glucose level | 2-hour | Plasma glucose assessed 2-hr after oral glucose tolerance test. |
| Oral glucose sensitivity index | 2-hour | Oral glucose sensitivity index derived from glucose and insulin values throughout the 2-hr oral glucose tolerance test |
| Glucagon area under the curve | 2-hour | Glucagon area under the curve during oral glucose tolerance test |
Countries
Canada
Outcome results
None listed