Heart and Kidney Ketones Metabolism

July 18, 2023 updated by: Université de Sherbrooke

Exogenous Ketone Salt on Heart and Kidney Ketone Metabolism Measured by Positron Emission Tomography

Participants will undergo 3 Positron Emission Tomography (PET) scans in 3 different conditions :

  1. Fasting without exogenous ketone salt
  2. Fasting with exogenous ketone salt supplement
  3. Post-Prandial with exogenous ketone salt supplement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will help to quantify heart and kidney ketone uptake with or without an exogenous ketone salt with or without food intake in middle-aged adults. Participants will have 3 different PET scan to perform :

  1. Fasting without exogenous ketone salt
  2. Fasting with exogenous ketone salt supplement
  3. Post-Prandial with exogenous ketone salt supplement.

Study Type

Interventional

Enrollment (Actual)

10

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
        • Rearsh Centre on Aging

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

45 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Aged between 45 and 64
  • Generally Healthy
  • BMI between 18.5 and 27

Exclusion Criteria:

  • All drugs taken on a daily basis
  • Diabetes or pre-diabetes
  • Digestive dysfunction
  • Pregnancy or lactation
  • Allergy to the supplement
  • Participate in an intensive physical exercise training (more than three times a week)
  • Being on a ketogenic diet or consumption of ketogenic supplement.
  • More than 2 alcoholic beverages each day
  • Any clinically significant anomaly in the blood profile
  • Smoking
  • Claustrophobia
  • Being enrolled in another interventional research project or in a PET research project
  • Unable to lie dorsally supine for at least 60 minutes

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Fasting without exogenous ketone salt supplement
Experimental: Fasting with exogenous ketone salt supplement
Dietary supplement: Fasting with exogenous ketone salt supplement
Participants will have to take 2 doses of supplement, one 75 minutes before the scan and one 30 minutes before the scan.
Other Names:
  • Post-Prandial with exogenous ketone salt supplement
Experimental: Post-Prandial with exogenous ketone salt supplement
Dietary supplement: Post-Prandial with exogenous ketone salt supplement
Participants will have to take 2 doses of supplement, one 75 minutes before the scan and one 30 minutes before the scan and they will have a liquid meal 20 minutes before the scan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
11C-Acetoacetate Heart Ketone uptake
Time Frame: 60 minutes
Heart ketone uptake measured by PET scan
60 minutes
11C-Acetoacetate Kidney ketone uptake
Time Frame: 60 minutes
Kidney ketone uptake measured by PET scan
60 minutes
Cardiac Functions, telediastolic volume
Time Frame: 60 minutes
telediastolic volume
60 minutes
Cardiac Functions, telesystolic volume
Time Frame: 60 minutes
telesystolic volume
60 minutes
Cardiac functions, ejection fraction
Time Frame: 60minutes
Ejection fraction
60minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma ketone
Time Frame: 60 minutes
Plasma ketone concentration
60 minutes

Collaborators and Investigators

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

Sponsor

Université de Sherbrooke

Collaborators

Société des Produits Nestlé (SPN)

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 (Actual)

October 15, 2020

Primary Completion (Actual)

August 15, 2022

Study Completion (Actual)

January 15, 2023

Study Registration Dates

First Submitted

July 7, 2020

First Submitted That Met QC Criteria

October 7, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Actual)

July 19, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2020-3441

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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