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

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.

Study Overview

• Status: Recruiting
• Conditions: Blood Glucose; Ketosis
• Intervention / Treatment: Dietary supplement: (R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester; Dietary supplement: Beta-hydroxybutyric acid; Dietary supplement: 1,3-Butanediol

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jonathan Little, PhD; Phone Number: 2508079876; Email: jonathan.little@ubc.ca
• Study Contact Backup: Name: Kaja Falkenhain; Phone Number: 2508079122; Email: kajaf@mail.ubc.ca

Study Locations

• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1V 1V7
      • Recruiting
      • University of British Columbia Okanagan
      • Contact: Jonathan P Little; Phone Number: 2508079876; Email: jonathan.little@ubc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: March 1, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 10, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 22, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Acid-Base Imbalance; Acidosis; Ketosis
• Other Study ID Numbers: H22-00083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The investigators will share individual patient data (de-identified) with researchers upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No