The Effect of Different Ketone Supplements on Blood β-OHB and Blood Glucose in Healthy Individuals
Primary Purpose
Ketosis, Blood Glucose
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
(R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester
Beta-hydroxybutyric acid
1,3-Butanediol
Sponsored by
About this trial
This is an interventional other trial for Ketosis
Eligibility Criteria
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
Sites / Locations
- University of British Columbia OkanaganRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
(R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester
Beta-hydroxybutyric acid
1,3-Butanediol
Arm Description
1 x 20 mL
1 x 237 mL
1 x 35 mL
Outcomes
Primary Outcome Measures
Blood beta-hydroxybutyrate
Are under the curve (AUC)
Secondary Outcome Measures
Blood glucose
Area under the curve (AUC)
Blood pressure
Change over time
Heart rate
Change over time
Supplement acceptability & taste
Questionnaire
Hunger & fullness
Questionnaire
Gastrointestinal discomfort
Questionnaire
Full Information
NCT ID
NCT05273411
First Posted
March 1, 2022
Last Updated
April 22, 2022
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT05273411
Brief Title
The Effect of Different Ketone Supplements on Blood β-OHB and Blood Glucose in Healthy Individuals
Official Title
The Effect of Different Ketone Supplements on Blood β-OHB and Blood Glucose in Healthy Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 24, 2022 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ketosis, Blood Glucose
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
(R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester
Arm Type
Active Comparator
Arm Description
1 x 20 mL
Arm Title
Beta-hydroxybutyric acid
Arm Type
Experimental
Arm Description
1 x 237 mL
Arm Title
1,3-Butanediol
Arm Type
Experimental
Arm Description
1 x 35 mL
Intervention Type
Dietary Supplement
Intervention Name(s)
(R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester
Other Intervention Name(s)
Exogenous Ketones
Intervention Description
Single-dose pharmacokinetic study over 4 hours.
Intervention Type
Dietary Supplement
Intervention Name(s)
Beta-hydroxybutyric acid
Other Intervention Name(s)
Exogenous Ketones
Intervention Description
Beta-hydroxybutyric acid
Intervention Type
Dietary Supplement
Intervention Name(s)
1,3-Butanediol
Other Intervention Name(s)
Exogenous Ketones
Intervention Description
1,3-Butanediol
Primary Outcome Measure Information:
Title
Blood beta-hydroxybutyrate
Description
Are under the curve (AUC)
Time Frame
240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation)
Secondary Outcome Measure Information:
Title
Blood glucose
Description
Area under the curve (AUC)
Time Frame
240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation)
Title
Blood pressure
Description
Change over time
Time Frame
240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation)
Title
Heart rate
Description
Change over time
Time Frame
240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation)
Title
Supplement acceptability & taste
Description
Questionnaire
Time Frame
240 minutes post-supplementation
Title
Hunger & fullness
Description
Questionnaire
Time Frame
240 minutes post-supplementation
Title
Gastrointestinal discomfort
Description
Questionnaire
Time Frame
60 minutes post-supplementation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Little, PhD
Phone
2508079876
Email
jonathan.little@ubc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Kaja Falkenhain
Phone
2508079122
Email
kajaf@mail.ubc.ca
Facility Information:
Facility Name
University of British Columbia Okanagan
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1V 1V7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan P Little
Phone
2508079876
Email
jonathan.little@ubc.ca
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
The investigators will share individual patient data (de-identified) with researchers upon request.
Learn more about this trial
The Effect of Different Ketone Supplements on Blood β-OHB and Blood Glucose in Healthy Individuals
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