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Completed

NCT Number: NCT05273411

The Effect of Different Ketone Supplements on 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.

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Key information

Conditions

Ketosis Acid-Base Imbalance Acidosis Blood Glucose Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia Okanagan

Kelowna, British Columbia, V1V 1V7, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Dietary Supplement

Single-dose pharmacokinetic study over 4 hours.

Other names: Exogenous Ketones

Beta-hydroxybutyric acid

Dietary Supplement

Beta-hydroxybutyric acid

Other names: Exogenous Ketones

1,3-Butanediol

Dietary Supplement

1,3-Butanediol

Other names: Exogenous Ketones

Primary outcomes

  1. Blood Beta-hydroxybutyrate

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

    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)

Secondary outcomes

  1. Blood Glucose

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

    Area under the curve (AUC)

  2. Blood Pressure

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

    Change over time

  3. Heart Rate

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

    Change over time

  4. Supplement Acceptability & Taste

    Time frame: 240 minutes post-supplementation

    Questionnaire

  5. Hunger & Fullness

    Time frame: 240 minutes post-supplementation

    Questionnaire

  6. Gastrointestinal Discomfort

    Time frame: 60 minutes post-supplementation

    Questionnaire

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 10, 2022
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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