Heart and Kidney Ketones Metabolism

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04580823
• Other study ID #: 2020-3441
• Status: Completed
• Phase: N/A
• Start date: October 15, 2020
• Est. completion date: January 15, 2023

Study information

• Verified date: July 2023
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 15, 2023
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Rearsh Centre on Aging	Sherbrooke	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université de Sherbrooke	Société des Produits Nestlé (SPN)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	11C-Acetoacetate Heart Ketone uptake	Heart ketone uptake measured by PET scan	60 minutes
Primary	11C-Acetoacetate Kidney ketone uptake	Kidney ketone uptake measured by PET scan	60 minutes
Primary	Cardiac Functions, telediastolic volume	telediastolic volume	60 minutes
Primary	Cardiac Functions, telesystolic volume	telesystolic volume	60 minutes
Primary	Cardiac functions, ejection fraction	Ejection fraction	60minutes
Secondary	Plasma ketone	Plasma ketone concentration	60 minutes