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

Ketosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05273411
• Other study ID #: H22-00083
• Status: Recruiting
• Phase: N/A
• Start date: March 24, 2022
• Est. completion date: December 2022

Study information

• Verified date: April 2022
• Source: University of British Columbia
• Contact: Jonathan Little, PhD
• Phone: 2508079876
• Email: jonathan.little[@]ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Glucose
• Ketosis

Intervention

Dietary Supplement:
• (R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester
Single-dose pharmacokinetic study over 4 hours.
• Beta-hydroxybutyric acid
Beta-hydroxybutyric acid
• 1,3-Butanediol
1,3-Butanediol

Locations

Country	Name	City	State
Canada	University of British Columbia Okanagan	Kelowna	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

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