Clinical trial NCT05155410: Examining the Effect of Exogenous Ketone Supplementation on Glucose Control in Type 2 Diabetes
Official title: Effect of 14 Days of Exogenous Ketone Supplementation on Glycemic Control in Type 2 Diabetes: a Randomized Placebo-controlled Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: 3-Hydroxybutyric Acid
Glycemic Control
Hyperglycemia
Ketones
Glucose Control
Inflammation
Immune cell function
Cognition
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2021-12-13
Enrollment: 15
Sex: ALL
Minimum age (years): 30
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Ketone bodies are a fuel source and signaling molecule that are produced by the body during prolonged fasting or if an individuals consistently eats a low-carbohydrate "keto" diet. Blood ketones can be used as a source of energy by the body, but they may also act as signals that impact the functioning of different cells in the body. Recently, the availability of ketone supplements that can be taken orally allows for raising blood ketones without having to fast or eat a "keto" diet. The investigators' studies and those of other researchers have shown that ketone supplementation can lower blood sugar without having to make any other dietary changes. Oral ingestion of ketones may therefore be an effective strategy to improve blood sugar control and influence how cells function.

The main objective of this study is to determine if consuming a ketone supplement 3 times per day (before meals) for 14 days lowers blood sugar and impacts how the body's cells function. The results of this study will be used to guide future recommendations on the utility of ketone supplements for improving health in individuals with, or at elevated risk of, type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Have a type 2 diabetes diagnosis from a physician
* Have stable use of glucose-lowering medications for at least 3 months

Exclusion Criteria:

* Are a competitively trained endurance athlete
* Are actively attempting to gain or lose weight
* Have a history of mental illness or existing neurological disease(s), cardiovascular events (i.e., heart attack, stroke) in the last 2 years
* Have hypoglycemia, irritable bowel syndrome or inflammatory bowel disease
* Are currently using insulin or SGLT2 inhibitors
* Are using more than 2 classes of glucose-lowering medication
* Are currently following a ketogenic diet or taking ketone supplements
* Are unable to commit for a 29-day trial
* Are unable to follow a controlled diet

Primary outcomes:
measure: Glucose Control: Change in Fructosamine
timeFrame: Day 14 (post-intervention)
Secondary outcomes:
measure: Vascular function
timeFrame: Day 0 (Pre-intervention) and Day 14 (post-intervention)
measure: Cognition: N-back test
timeFrame: Day 0 (Pre-intervention) and Day 14 (post-intervention)
measure: Cognition: Digit-symbol substitution test
timeFrame: Day 0 (Pre-intervention) and Day 14 (post-intervention)
measure: Change from baseline plasma insulin at 14 days
timeFrame: Day 0 (Pre-intervention) and Day 14 (post-intervention)
measure: Change from baseline plasma free fatty acids at 14 days
timeFrame: Day 0 (Pre-intervention) and Day 14 (post-intervention)
measure: Change from baseline circulating inflammatory cytokines at 14 days
timeFrame: Day 0 (Pre-intervention) and Day 14 (post-intervention)
measure: Phagocytosis
timeFrame: Day 0 (Pre-intervention) and Day 14 (post-intervention)
measure: Oxidative Burst
timeFrame: Day 0 (Pre-intervention) and Day 14 (post-intervention)
measure: Degranulation
timeFrame: Day 0 (Pre-intervention) and Day 14 (post-intervention)
measure: Immune Cell Phenotyping
timeFrame: Day 0 (Pre-intervention) and Day 14 (post-intervention)
measure: Complete blood count
timeFrame: Day 0 (Pre-intervention) and Day 14 (post-intervention)
measure: Glycemic Control: 2hr postprandial hyperglycemia
timeFrame: Day 1 through to Day 10
measure: Glycemic Control: 24hr average glucose area under the curve (AUC)
timeFrame: Day 1 through to Day 10
measure: Glycemic Control: Fasting glucose
timeFrame: Day 1 through to Day 10
measure: Glycemic Control: Change in Fasting Plasma glucose
timeFrame: Day 14
measure: Glycemic Control: Glycemic variability
timeFrame: Day 1 through to Day 10
measure: Glycemic Control: Time in Target Range
timeFrame: Day 1 through to Day 10
measure: Glycemic Control: HbA1c
timeFrame: Day 0 (pre-intervention) and Day 14 (post-intervention)
measure: Lipid Panel
timeFrame: Day 0 (pre-intervention) and Day 14 (post-intervention)
measure: Body weight
timeFrame: Day 0 (pre-intervention) and Day 14 (post-intervention)
measure: Blood pressure
timeFrame: Day 0 (pre-intervention) and Day 14 (post-intervention)
measure: Blood beta-hydroxybutyrate
timeFrame: Day 0 (pre-intervention) and Day 14 (post-intervention)
measure: Physical activity
timeFrame: Day 0 (pre-intervention) to Day 14 (post-intervention)
measure: Sedentary time
timeFrame: Day 0 (pre-intervention) to Day 14 (post-intervention)
measure: Sleeping time
timeFrame: Day 0 (pre-intervention) to Day 14 (post-intervention)
measure: Resting heart rate
timeFrame: Day 0 (pre-intervention) and Day 14 (post-intervention)
measure: Waist circumference
timeFrame: Day 0 (pre-intervention) and Day 14 (post-intervention)
Other outcomes:
measure: Supplement acceptability
timeFrame: Day 14
measure: Hunger and fullness cravings questionnaire
timeFrame: Day 0 (Pre-intervention) through to Day 3
measure: T cell Activation
timeFrame: Day 0 (Pre-intervention) and Day 14 (post-intervention)
measure: Cravings
timeFrame: Day 0 (Pre-intervention) and Day 14 (post-intervention)
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia Okanagan
state: British Columbia
Study officials:
affiliation: University of British Columbia- Okanagan
name: Jonathan Little, PhD
role: PRINCIPAL_INVESTIGATOR
References: