Exogenous Ketones and Glucose Tolerance
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ketone monoester Acute morning dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.45 ml/kg body weight) |
Dietary Supplement: Ketone monoester
Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior a 2-hour oral glucose tolerance test.
|
| Placebo Comparator: Placebo Acute morning dose of flavour-matched placebo. |
Dietary Supplement: Placebo
Acute ingestion of a taste-matched placebo prior a 2-hour oral glucose tolerance test.
|
Outcome Measures
Primary Outcome Measures
- Glucose area under the curve [2-hour]
Area under the curve for glucose during oral glucose tolerance test
Secondary Outcome Measures
- Insulin area under the curve [2-hour]
Insulin area under the curve 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
- 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
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Not taking any medications affecting glucose metabolism.
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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:
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Diagnosed with diabetes.
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Diagnosed with heart disease.
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Competitive endurance athlete (self-identified as engaged in specific endurance training in triathlon, cycling, or distance running and competing in races or competition)
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Recent (last 3 months) or current consumption of a low-carbohydrate ketogenic diet
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Current consumption of ketone supplements
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Pregnant or planning to become pregnant during the study (if female)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of British Columbia, Okanagan. | Kelowna | British Columbia | Canada | V1V 1V7 |
Sponsors and Collaborators
- University of British Columbia
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H16-01846