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

NCT05273411 | Completed Results

• 1 other identifier: H22-00083
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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)

  240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation)

Secondary Outcomes (6)

• Blood Glucose

  240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation)

• Blood Pressure

  240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation)

• Heart Rate

  240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation)

• Supplement Acceptability & Taste

  240 minutes post-supplementation

• Hunger & Fullness

  240 minutes post-supplementation

Study Arms (3)

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

ACTIVE COMPARATOR

1 x 20 mL

Dietary Supplement: (R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester

Beta-hydroxybutyric acid

EXPERIMENTAL

1 x 237 mL

Dietary Supplement: Beta-hydroxybutyric acid

1,3-Butanediol

EXPERIMENTAL

1 x 35 mL

Dietary Supplement: 1,3-Butanediol

Interventions

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

Single-dose pharmacokinetic study over 4 hours.

Also known as: Exogenous Ketones

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

Beta-hydroxybutyric acid DIETARY_SUPPLEMENT

Beta-hydroxybutyric acid

Also known as: Exogenous Ketones

Beta-hydroxybutyric acid

1,3-Butanediol DIETARY_SUPPLEMENT

1,3-Butanediol

Also known as: Exogenous Ketones

1,3-Butanediol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• over the age of 18;
• able to fast overnight

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia Okanagan

Kelowna, British Columbia, V1V 1V7, Canada

Location

MeSH Terms

Conditions

Ketosis

Interventions

3-Hydroxybutyric Acid; 1,3-butylene glycol

Condition Hierarchy (Ancestors)

Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hydroxybutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Ketone Bodies; Ketones; Fatty Acids, Volatile; Fatty Acids; Lipids

Results Point of Contact

• Title: Jonathan Little, PhD
• Organization: University of British Columbia

jonathan.little@ubc.ca

2508079876

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Jonathan Little, Associate Professor

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 10, 2022
• Study Start: March 24, 2022
• Primary Completion: May 18, 2022
• Study Completion: May 18, 2022
• Last Updated: August 1, 2024
• Results First Posted: August 1, 2024

Record last verified: 2024-02

Locations

CA (1)