Evaluation of the Ketogenic Potential of Different Diet Supplements

March 24, 2020 updated by: Université de Sherbrooke

Stimulating the Ketogenesis by Using Nutritional Supplements

Evaluate the capacity of different dietary supplements to increase ketone production in healthy adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to evaluate the capacity of different dietary supplements to increase ketone production in healthy adults. Each supplement (leucine, butyrate, octanoate, carnitine or butter fraction rich in MCT) is evaluated for a period of 4-hour during which multiple blood samples are taken in order to measure ketone production.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H4C4
        • Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy adults aged of 18 years old or older.
  • Non-smoking.

Exclusion Criteria:

  • Diabetes or prediabetes
  • Uncontrolled hypertension
  • Uncontrolled thyroid function
  • Taking medication that will affect lipid/glucose metabolism
  • Severe infection or inflammation
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ketogenic potential

Each participant has to go through a total of 8 visits, each visit corresponding to a standardize breakfast taken alone (control visit) or with one of the dietary supplements evaluated followed by a period of 4-hour with multiple blood sampling.

Intervention 1: Control; no supplement Intervention 2: 5 g of leucine Intervention 3: 3.6 g of butyrate Intervention 4: 7.2 g of butyrate Intervention 5: 5 g of octanoate Intervention 6: 10 g of octanoate Intervention 7: 1.95 g of carnitine Intervention 8: 65 g of butter fraction rich in MCT
Dietary supplement: Control
Visit corresponding to a standardize breakfast taken alone (control visit) followed by a period of 4-hour with multiple blood sampling.
Other Names:
  • CTL
Dietary supplement: Leucine
Visit corresponding to a standardize breakfast with 5 g of leucine followed by a period of 4-hour with multiple blood sampling.
Dietary supplement: Butyrate -
Visit corresponding to a standardize breakfast with 3.6 g of butyrate followed by a period of 4-hour with multiple blood sampling.
Dietary supplement: Butyrate +
Visit corresponding to a standardize breakfast with 7.2 g of butyrate followed by a period of 4-hour with multiple blood sampling.
Dietary supplement: Octanoate -
Visit corresponding to a standardize breakfast with 5 g of octanoate followed by a period of 4-hour with multiple blood sampling.
Dietary supplement: Octanoate +
Visit corresponding to a standardize breakfast with 10 g of octanoate followed by a period of 4-hour with multiple blood sampling.
Dietary supplement: Carnitine
Visit corresponding to a standardize breakfast with 1.95 g of carnitine followed by a period of 4-hour with multiple blood sampling.
Dietary supplement: Butter fraction
Visit corresponding to a standardize breakfast with 65 g of butter fraction followed by a period of 4-hour with multiple blood sampling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of Total Plasma Ketones
Time Frame: 4 hours

Difference from Time 0 in Total ketones = acetoacetate (umol/L) + beta-hydroxybutyrate (umol/L) Time 0 is when the participants arrived, after a 12 hours fast, i.e. before the breakfast.

Plasma was collected every 30 minutes for 4 hours immediately following breakfast (where supplements were taken).

Results are the mean of plasma ketones measured every 30 minutes ( i.e. total of 9 plasma samples) for the 4 hour period.

For each time point, the difference form time 0 has been made. So this is the mean of the difference from time 0 in total ketones.

Data were not collected for the 'Intervention 8: 65 g of butter fraction rich in MCT' supplement.
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Investigators

  • Principal Investigator: Stephen Cunnane, PhD, Research Centre on Aging CSSS-IUGS - CIUSSS de l'Estrie - CHUS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

February 23, 2016

First Submitted That Met QC Criteria

February 23, 2016

First Posted (Estimate)

February 26, 2016

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2014-387

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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