Blood Glucose, Ketosis
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENT(R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester
Single-dose pharmacokinetic study over 4 hours.
DIETARY_SUPPLEMENTBeta-hydroxybutyric acid
Beta-hydroxybutyric acid
DIETARY_SUPPLEMENT1,3-Butanediol
1,3-Butanediol
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Beta-hydroxybutyrate | 240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation) | Are under the curve (AUC) across 240 minutes after supplement consumption (assessed at baseline and 15, 30, 60, 90, 120, 180, and 240 post-supplementation) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | 240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation) | Change over time |
| Heart Rate | 240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation) | Change over time |
| Blood Glucose | 240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation) | Area under the curve (AUC) |
| Hunger & Fullness | 240 minutes post-supplementation | Questionnaire |
| Gastrointestinal Discomfort | 60 minutes post-supplementation | Questionnaire |
| Supplement Acceptability & Taste | 240 minutes post-supplementation | Questionnaire |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Single-dose pharmacokinetic study over 4 hours, three-way crossover study of three different ketone supplements (see description). | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | All Participants | — |
|---|---|---|
| Age, Continuous | 29.1 years STANDARD_DEVIATION 4.9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 12 participants | — |
| Sex: Female, Male Female | 5 Participants | — |
| Sex: Female, Male Male | 7 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 12 | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 12 |
Outcome results
Primary
Blood Beta-hydroxybutyrate
Are under the curve (AUC) across 240 minutes after supplement consumption (assessed at baseline and 15, 30, 60, 90, 120, 180, and 240 post-supplementation)
Time frame: 240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| (R)-3-hydroxybutyl (R)-3-hydroxybutyrate Ketone Monoester | Blood Beta-hydroxybutyrate | 217 area under the curve (mmol/L x 240 min) | Standard Deviation 51 |
| Beta-hydroxybutyric Acid | Blood Beta-hydroxybutyrate | 192 area under the curve (mmol/L x 240 min) | Standard Deviation 63 |
| 1,3-Butanediol | Blood Beta-hydroxybutyrate | 176 area under the curve (mmol/L x 240 min) | Standard Deviation 59 |
Secondary
Blood Glucose
Area under the curve (AUC)
Time frame: 240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation)
Secondary
Blood Pressure
Change over time
Time frame: 240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation)
Secondary
Gastrointestinal Discomfort
Questionnaire
Time frame: 60 minutes post-supplementation
Secondary
Heart Rate
Change over time
Time frame: 240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation)
Secondary
Hunger & Fullness
Questionnaire
Time frame: 240 minutes post-supplementation
Secondary
Supplement Acceptability & Taste
Questionnaire
Time frame: 240 minutes post-supplementation