Clinical trial NCT05273411: The Effect of Different Ketone Supplements on β-OHB and Blood Glucose in Healthy Individuals
Official title: The Effect of Different Ketone Supplements on Blood Beta-hydroxybutyrate (β-OHB) and Blood Glucose in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ketosis
Blood Glucose
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Blood Beta-hydroxybutyrate
timeFrame: 240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation)
Secondary outcomes:
measure: Blood Glucose
timeFrame: 240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation)
measure: Blood Pressure
timeFrame: 240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation)
measure: Heart Rate
timeFrame: 240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation)
measure: Supplement Acceptability & Taste
timeFrame: 240 minutes post-supplementation
measure: Hunger & Fullness
timeFrame: 240 minutes post-supplementation
measure: Gastrointestinal Discomfort
timeFrame: 60 minutes post-supplementation
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia Okanagan
state: British Columbia
Study officials:
References: