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NCT Number: NCT04194450

Exogenous Ketones in Type 2 Diabetes

Exogenous ketone supplements are proposed to have glucose-lowering potential, provide an alternative fuel for the brain and to enhance cognitive function. No studies have tested whether exogenous ketones can lower blood glucose in people with type 2 diabetes. In addition, the impact of exogenous ketones on brain blood flow, cognitive function or brain-derived neurotrophic factor in humans is unknown. The purpose of this study is to determine if acutely ingesting exogenous ketones, in the form of a ketone monoester drink, can lower glucose and improve measures of brain/cognitive function in humans with type 2 diabetes. Participants will consume a ketone monoester drink or placebo with blood samples, brain blood flow, and cognitive function assessed over 180 minutes. The researchers will also test how the ketone monoester drink impacts appetite and measures of inflammation.

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Key information

Conditions

Ketosis Acid-Base Imbalance Acidosis Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

20 year–69 year

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: No

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

Inclusion criteria

  • physician-diagnosed type 2 diabetes of ≥1 year
  • current hemoglobin A1C (HbA1c) of 6.5-8.0%
  • treatment with lifestyle or stable (≥3 months) oral glucose-lowering medications
  • blood pressure of <160/99 mm Hg assessed according to guidelines
  • non-smoking
  • no prior history of cardiovascular disease or stroke
  • not on hormone replacement therapy, corticosteroids, or anti-inflammatory medications
  • 20-75 years old

Exclusion criteria

  • being a competitive endurance athlete
  • taking exogenous insulin or sodium glucose transporter 2 (SGLT2) inhibitors
  • following a ketogenic diet, low-calorie diet, periodic fasting regimen, or consume ketogenic supplements
  • being unable to travel to and from the university
  • being unable to follow the controlled diet instructions
  • being pregnant or planning to become pregnant during the study (if female)
  • disorders of fat metabolism, chronic pancreatitis, had gastric bypass surgery and/or gallbladder disease
  • being unable to read or communicate in English

Treatment and study plan

Ketone monoester

Dietary Supplement

Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior to assessment of outcomes.

Placebo

Dietary Supplement

Acute ingestion of taste-matched placebo prior to assessment of outcomes.

Primary outcomes

  1. Plasma Glucose

    Time frame: 180 minutes

    Plasma glucose concentration after ketone or placebo ingestion

Secondary outcomes

  1. Plasma Insulin

    Time frame: 180 minutes

    Insulin across concentration after ketone or placebo ingestion

  2. Plasma C-peptide

    Time frame: 180 minutes

    C-peptide across concentration after ketone or placebo ingestion

  3. Plasma Free Fatty Acids

    Time frame: 180 minutes

    Non-esterified fatty acid concentration after ketone or placebo ingestion

  4. Plasma Tumour Necrosis Factor Alpha

    Time frame: 180 minutes

    Plasma tumour necrosis factor alpha concentration after ketone or placebo ingestion

  5. Plasma Tumour Interleukin-1beta

    Time frame: 180 minutes

    Plasma tumour interleukin-1beta concentration after ketone or placebo ingestion

  6. Plasma Tumour Interleukin-6

    Time frame: 180 minutes

    Plasma tumour interleukin-6 concentration after ketone or placebo ingestion

  7. Cerebral Blood Flow

    Time frame: 180 minutes

    Intracranial blood flow velocity measured by ultrasound

  8. Blood Pressure

    Time frame: 180 minutes

    Blood pressure measured manually and by Finipres

  9. Cognitive Function - Digital Symbol Substitution Task

    Time frame: 180 minutes

    Number of Correct Answers on the Digital Symbol Substitution Task. Measure of cognitive function using Brain Baseline battery on an iPad.

  10. Brain-derived Neurotrophic Factor

    Time frame: 180 minutes

    Brain-derived neurotrophic factor concentrations after ketone or placebo ingestion

  11. Number Blood Monocytes (x10^3 Cells/uL)

    Time frame: 180 minutes

    Total blood monocytes count (x10^3 cells/uL) after ketone or placebo ingestion

  12. Self Reported Hunger and Fullness

    Time frame: 180 minutes

    Self reported hunger and fullness by a 0 to 100 mm Visual Analog Scale (higher scores mean greater hunger or fullness)

  13. Gastrointestinal Symptoms

    Time frame: 180 minutes

    Gastrointestinal symptom questionnaire scores after ketone or placebo ingestion on a 0 to 100 mm Visual Analog Scale (higher scores mean greater symptoms)

  14. Total Energy Consumed

    Time frame: 180 minutes after ketone or placebo ingestion

    Total energy consumed in kilocalories in buffet style meal after ketone or placebo ingestion

  15. Monocyte Histone Acetylation

    Time frame: 180 minutes

    Histone acetylation status of monocytes measured after ketone or placebo ingestion

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

The Effect of Acute Exogenous Oral Ketone Supplementation on Blood Glucose Levels in Type 2 Diabetes

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 11, 2019
Registry last updated
May 30, 2025

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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