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Clinical Trials/NCT05273411
NCT05273411CompletedNot Applicable

The Effect of Different Ketone Supplements on Blood Beta-hydroxybutyrate (β-OHB) and Blood Glucose in Healthy Individuals

University of British Columbia1 site in 1 country12 target enrollmentStarted: March 24, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
12
Locations
1
Primary Endpoint
Blood Beta-hydroxybutyrate

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

(R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester

Active Comparator

1 x 20 mL

Intervention: (R)-3-hydroxybutyl (R)-3-hydroxybutyrate ketone monoester (Dietary Supplement)

Beta-hydroxybutyric acid

Experimental

1 x 237 mL

Intervention: Beta-hydroxybutyric acid (Dietary Supplement)

1,3-Butanediol

Experimental

1 x 35 mL

Intervention: 1,3-Butanediol (Dietary Supplement)

Outcomes

Primary Outcomes

Blood Beta-hydroxybutyrate

Time Frame: 240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation)

Are under the curve (AUC) across 240 minutes after supplement consumption (assessed at baseline and 15, 30, 60, 90, 120, 180, and 240 post-supplementation)

Secondary Outcomes

  • Blood Pressure(240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation))
  • Supplement Acceptability & Taste(240 minutes post-supplementation)
  • Hunger & Fullness(240 minutes post-supplementation)
  • Gastrointestinal Discomfort(60 minutes post-supplementation)
  • Blood Glucose(240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation))
  • Heart Rate(240 minutes (assessed at baseline and 15, 30, 60, 90, 120, 180, 240 minutes post-supplementation))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jonathan Little

Dr. Jonathan Little, Associate Professor

University of British Columbia

Study Sites (1)

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