Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effects of Exogenous Ketones on Glucose Tolerance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04088617
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Jonathan Little, University of British Columbia

Brief Summary:
The ketone body beta-hydroxybutyrate is produced during prolonged fasting or when endogenous carbohydrate stores are depleted and can be used as an alternative fuel source. Exogenous beta-hydroxybutyrate, in the form of a ketone monoester, is proposed to have glucose-lowering potential but this has not been adequately studied. The purpose of this study is to determine whether supplementing with an acute dose of ketone monoester can improve the glycemic response to a high carbohydrate mixed meal in young healthy individuals.

Condition or disease Intervention/treatment Phase
Dietary Supplement: Ketone Supplement Dietary Supplement: Placebo Dietary Supplement: Ketone monoester Dietary Supplement: Placebo Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Crossover assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Placebo masked with flavouring and participants consume in opaque containers
Primary Purpose: Basic Science
Official Title: The Effects of Exogenous Ketones on Glucose Tolerance
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : January 31, 2020

Arm Intervention/treatment
Experimental: Ketone monoester
Acute morning dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.45 ml/kg body weight)
Dietary Supplement: Ketone monoester
Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior a 2-hour high carbohydrate mixed meal tolerance test.

Placebo Comparator: Placebo
Acute morning dose of flavour-matched placebo.
Dietary Supplement: Placebo
Acute ingestion of a taste-matched placebo prior a 2-hour high carbohydrate mixed meal tolerance test.




Primary Outcome Measures :
  1. Glucose area under the curve [ Time Frame: 2-hour ]
    Area under the curve for glucose during high carbohydrate mixed meal tolerance test


Secondary Outcome Measures :
  1. Insulin area under the curve [ Time Frame: 2-hour ]
    Insulin area under the curve during high carbohydrate mixed meal tolerance test

  2. Free fatty acids area under the curve [ Time Frame: 2-hour ]
    Non-esterified fatty acids area under the curve during high carbohydrate mixed meal tolerance test

  3. Glucose incremental area under the curve [ Time Frame: 2-hour ]
    Incremental area under the curve (above baseline) for glucose during high carbohydrate mixed meal tolerance test

  4. Insulin incremental area under the curve [ Time Frame: 2-hour ]
    Incremental area under the curve (above baseline) for insulin during high carbohydrate mixed meal tolerance test

  5. 2-hr glucose level [ Time Frame: 2-hour ]
    Plasma glucose assessed 2-hr after high carbohydrate mixed meal tolerance test

  6. Beta-hydroxybutyrate level [ Time Frame: 2-hour ]
    Blood beta-hydroxybutyrate concentration assessed by handheld monitor



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Young healthy individuals
  • Not taking any medications affecting glucose metabolism

Exclusion Criteria:

  • Competitive endurance athlete (i.e., train specifically for cycling, triathlon or distance running and compete at a high level)
  • Diagnosed with the chronic medical condition that may impact consumption of carbohydrates or supplements (e.g., diabetes, heart disease)
  • Are currently using medications that may interfere with insulin sensitivity
  • Adhere to a strict high-fat low-carbohydrate or ketogenic diet (within the last 3 months)
  • Are currently using ketone supplements
  • Unable to travel to and from the university in order to make your testing appointments.
  • Unable to follow the controlled diet instructions required for the study.
  • If pregnant or are planning to become pregnant during the study (if female)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04088617


Contacts
Layout table for location contacts
Contact: Jonathan P Little, PhD 2508786893 jonathan.little@ubc.ca

Locations
Layout table for location information
Canada, British Columbia
University of British Columbia, Okanagan Recruiting
Kelowna, British Columbia, Canada, V1V 1V7
Contact: Jonathan Little, PhD    2508079876    jonathan.little@ubc.ca   
Sponsors and Collaborators
University of British Columbia

Layout table for additonal information
Responsible Party: Jonathan Little, Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT04088617     History of Changes
Other Study ID Numbers: H16-01846-B
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No