Exogenous Ketones in Type 2 Diabetes

Not Applicable

Completed

• Conditions: Ketosis; Type 2 Diabetes
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Ketone monoester

• Registration Number: NCT04194450
• Lead Sponsor: University of British Columbia

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-09
• Study First Posted: 2019-12-11
• Study Start: 2020-01-15
• Primary Completion: 2022-05-20
• Study Completion: 2022-05-20
• Status Verified: 2022-07
• Results First Submitted: 2023-03-14
• Results First Submitted QC: 2023-03-14
• Last Update Submitted: 2023-03-14
• Results First Posted: 2023-12-11
• Last Update Posted: 2023-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Acute dose of flavour-matched placebo.
Ketone monoester	Ketone monoester	Acute dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.3 g/kg body weight)

Primary Outcome Measures

Name	Time	Method
Plasma Glucose	180 minutes	Plasma glucose concentration after ketone or placebo ingestion

Secondary Outcome Measures

Name	Time	Method
Monocyte Histone Acetylation	180 minutes	Histone acetylation status of monocytes measured after ketone or placebo ingestion
Plasma Insulin	180 minutes	Insulin across concentration after ketone or placebo ingestion
Brain-derived Neurotrophic Factor	180 minutes	Brain-derived neurotrophic factor concentrations after ketone or placebo ingestion
Plasma C-peptide	180 minutes	C-peptide across concentration after ketone or placebo ingestion
Plasma Tumour Interleukin-1beta	180 minutes	Plasma tumour interleukin-1beta concentration after ketone or placebo ingestion
Plasma Tumour Interleukin-6	180 minutes	Plasma tumour interleukin-6 concentration after ketone or placebo ingestion
Blood Pressure	180 minutes	Blood pressure measured manually and by Finipres
Cognitive Function	180 minutes	Measures of cognitive function using Brain Baseline battery on an iPad.
Blood Monocytes	180 minutes	Total blood monocytes and monocyte subsets after ketone or placebo ingestion
Self Reported Hunger and Fullness	180 minutes	Self reported hunger and fullness by a 0 to 100 mm Visual Analog Scale (higher scores mean greater hunger or fullness)
Gastrointestinal Symptoms	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)
Plasma Tumour Necrosis Factor Alpha	180 minutes	Plasma tumour necrosis factor alpha concentration after ketone or placebo ingestion
Total Energy Consumed	180 minutes after ketone or placebo ingestion	Total energy consumed in kilocalories in buffet style meal after ketone or placebo ingestion
Plasma Free Fatty Acids	180 minutes	Non-esterified fatty acid concentration after ketone or placebo ingestion
Cerebral Blood Flow	180 minutes	Intracranial blood flow velocity measured by ultrasound

Trial Locations

Locations (1)

University of British Columbia, Okanagan; 🇨🇦 Kelowna, British Columbia, Canada