The Effect of Different Ketone Supplements on Blood β-OHB and Blood Glucose in Healthy Individuals

Study Overview
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Brief Summary
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Ketone bodies are a fuel source and signaling molecule that are produced by your body during prolonged fasting or if you consistently eat at low-carbohydrate diet. Blood ketones can be used as a source of energy during fasting and are used by your brain as an alternative source of fuel to glucose. Previous studies have found that ketones, when consumed in form of a supplement drink, can increase blood ketone levels and lower blood glucose, the amount of sugar in your blood. This is of potential interest for individuals with high blood sugar, such as people living with type 2 diabetes. However, there are different types of ketone supplements that differ in how they are metabolized in the body. Little is known about how these supplements affect blood ketone and blood glucose levels. The main objective of this study is to determine the effect of three different ketone supplements on blood ketones and blood glucose. The results of this pilot study will be used to guide future research for larger and more extensive studies on ketone supplements.

Official Title
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The Effect of Different Ketone Supplements on Blood β-OHB and Blood Glucose in Healthy Individuals

Conditions
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Ketosis, Blood Glucose

Intervention / Treatment
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* Dietary Supplement: (R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester
* Dietary Supplement: Beta-hydroxybutyric acid
* Dietary Supplement: 1,3-Butanediol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: over the age of 18; able to fast overnight Exclusion Criteria: being a competitive endurance athlete; following a ketogenic diet, low-calorie diet, periodic fasting regimen, or regularly consuming ketogenic supplements; being unable to travel to and from the university; being unable to follow the diet instructions; being pregnant or planning to become pregnant during the study; having been diagnosed with a chronic disorder of glucose or fat metabolism, including type 2 diabetes, chronic pancreatitis, or gallbladder disease; being unable to read or communicate in English

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: (R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester<br>1 x 20 mL | Dietary Supplement: (R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester<br>* Single-dose pharmacokinetic study over 4 hours.<br>* Other names: Exogenous Ketones;|
| Experimental: Beta-hydroxybutyric acid<br>1 x 237 mL | Dietary Supplement: Beta-hydroxybutyric acid<br>* Beta-hydroxybutyric acid<br>* Other names: Exogenous Ketones;|
| Experimental: 1,3-Butanediol<br>1 x 35 mL | Dietary Supplement: 1,3-Butanediol<br>* 1,3-Butanediol<br>* Other names: Exogenous Ketones;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood beta-hydroxybutyrate | Are under the curve (AUC) | 240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose | Area under the curve (AUC) | 240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation) | 
| Blood pressure | Change over time | 240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation) | 
| Heart rate | Change over time | 240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation) | 
| Supplement acceptability & taste | Questionnaire | 240 minutes post-supplementation | 
| Hunger & fullness | Questionnaire | 240 minutes post-supplementation | 
| Gastrointestinal discomfort | Questionnaire | 60 minutes post-supplementation |