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

NCT ID: NCT05273411

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-24
• Study Completion Date: 2022-05-18

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.

Conditions

Ketosis; Blood Glucose

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

(R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester

1 x 20 mL

Group Type: ACTIVE_COMPARATOR

(R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester

Intervention Type: DIETARY_SUPPLEMENT

Single-dose pharmacokinetic study over 4 hours.

Beta-hydroxybutyric acid

1 x 237 mL

Group Type: EXPERIMENTAL

Beta-hydroxybutyric acid

Intervention Type: DIETARY_SUPPLEMENT

Beta-hydroxybutyric acid

1,3-Butanediol

1 x 35 mL

Group Type: EXPERIMENTAL

1,3-Butanediol

Intervention Type: DIETARY_SUPPLEMENT

1,3-Butanediol

Interventions

(R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester

Single-dose pharmacokinetic study over 4 hours.

Intervention Type: DIETARY_SUPPLEMENT

Beta-hydroxybutyric acid

Beta-hydroxybutyric acid

Intervention Type: DIETARY_SUPPLEMENT

1,3-Butanediol

1,3-Butanediol

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Exogenous Ketones; Exogenous Ketones; Exogenous Ketones

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Little

Dr. Jonathan Little, Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of British Columbia Okanagan

Kelowna, British Columbia, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

H22-00083

Identifier Type: -

Identifier Source: org_study_id