The Effects of Exogenous Ketone Supplementation on Cardiovascular Function and Glucose Control
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Glucose control
Study Overview
Brief Summary
Post-prandial hyperglycemic excursions induce a cascade of deleterious effects on the body, including increased inflammation, production of reactive oxygen species, and impaired cardiovascular function. Ingestion of an exogenous oral ketone supplement blunts hyperglycemia in response to an oral glucose tolerance test. Accordingly, it is hypothesized that exogenous ketone supplement ingestion prior to a meal could be an effective strategy for blunting postprandial hyperglycemia. Therefore, the purpose of this study is to investigate the effect of short-term (14-days) pre-meal exogenous ketone supplementation on glucose control, cardiovascular function, inflammation, and oxidative stress in individuals at an elevated risk of type 2 diabetes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 69 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Elevated waist circumference (>102 cm for males, >88 cm for females) and/or Obesity (BMI > 30 kg/m2) and/or Diagnoses of prediabetes based on A1C (5.7-6.4%) and/or fasting plasma glucose (5.6-6.9 mmol/l) using ADA criteria
Exclusion Criteria
- •Competitively trained endurance athlete
- •Actively attempting to lose weight
- •History of mental illness or existing neurological disease(s)
- •Previous cardiovascular events (i.e., heart attack, stroke)
- •Diagnoses of diabetes
- •Hypoglycemia
- •Irritable bowel syndrome or inflammatory bowel disease
- •Taking medication that may interfere with insulin sensitivity
- •Currently following a ketogenic diet or taking ketone supplements
- •Unable to commit for 2 separate 14-day trials and unable to follow a controlled diet
Outcomes
Primary Outcomes
Glucose control
Time Frame: 2 hours after a meal
Post-prandial glucose excursions will be measured by continuous glucose monitoring using the iPro2 CGM by Medtronic in both the active and placebo supplement conditions. Post-prandial glucose following breakfast, lunch, and dinner will be averaged together.
Secondary Outcomes
- Change from baseline mitochondrial superoxide production at 14 days(Day 0 (Pre-intervention) and Day 14 (post-intervention))
- Change from baseline flow mediated dilation at 14 days(Day 0 (Pre-intervention) and Day 14 (post-intervention))
- Change from baseline histone acetylation at 14 days(Day 0 (Pre-intervention) and Day 14 (post-intervention))
- Change from baseline cognition (executive functions) at 14 days(Day 0 (Pre-intervention) and Day 14 (post-intervention))
- Change from baseline plasma glucose at 14 days(Day 0 (Pre-intervention) and Day 14 (post-intervention))
- Change from baseline plasma insulin at 14 days(Day 0 (Pre-intervention) and Day 14 (post-intervention))
- Change from baseline plasma free fatty acids at 14 days(Day 0 (Pre-intervention) and Day 14 (post-intervention))
- Change from baseline interleukin-1(IL)-1beta at 14 days(Day 0 (Pre-intervention) and Day 14 (post-intervention))
- Change from baseline caspase-1 activation at 14 days(Day 0 (Pre-intervention) and Day 14 (post-intervention))
Investigators
Jonathan Little
Assistant Professor
University of British Columbia