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OpenTrials
Completed

NCT Number: NCT04580823

Heart and Kidney Ketones Metabolism

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.

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Key information

Conditions

Healthy

Age range

45 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rearsh Centre on Aging

Sherbrooke, Quebec, J1H4C4, Canada

About this study

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 :

  • Fasting without exogenous ketone salt
  • Fasting with exogenous ketone salt supplement
  • Post-Prandial with exogenous ketone salt supplement.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fasting with exogenous ketone salt supplement

Dietary 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

Post-Prandial with exogenous ketone salt supplement

Dietary 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.

Primary outcomes

  1. 11C-Acetoacetate Heart Ketone uptake

    Time frame: 60 minutes

    Heart ketone uptake measured by PET scan

  2. 11C-Acetoacetate Kidney ketone uptake

    Time frame: 60 minutes

    Kidney ketone uptake measured by PET scan

  3. Cardiac Functions, telediastolic volume

    Time frame: 60 minutes

    telediastolic volume

  4. Cardiac Functions, telesystolic volume

    Time frame: 60 minutes

    telesystolic volume

  5. Cardiac functions, ejection fraction

    Time frame: 60minutes

    Ejection fraction

Secondary outcomes

  1. Plasma ketone

    Time frame: 60 minutes

    Plasma ketone concentration

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • Société des Produits Nestlé (SPN)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Oct 8, 2020
Registry last updated
Jul 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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