Heart and Kidney Ketones Metabolism

Sponsor

Université de Sherbrooke (Other)

Overall Status

Recruiting

CT.gov ID

NCT04580823

Collaborator

Nestlé (Industry)

Enrollment

Location

Arms

9.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: Fasting with exogenous ketone salt supplement Dietary Supplement: Post-Prandial with exogenous ketone salt supplement	N/A

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 :

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Each participant will have to do the 3 acute interventionsEach participant will have to do the 3 acute interventions

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Oct 15, 2020

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Fasting without exogenous ketone salt supplement
Experimental: Fasting with exogenous ketone salt supplement 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 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.

Arm

Intervention/Treatment

No Intervention: Control

Fasting without exogenous ketone salt supplement

Experimental: Fasting with exogenous ketone salt supplement

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

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.

Outcome Measures

Primary Outcome Measures

11C-Acetoacetate Heart Ketone uptake [60 minutes]
Heart ketone uptake measured by PET scan
11C-Acetoacetate Kidney ketone uptake [60 minutes]
Kidney ketone uptake measured by PET scan
Cardiac Functions, telediastolic volume [60 minutes]
telediastolic volume
Cardiac Functions, telesystolic volume [60 minutes]
telesystolic volume
Cardiac functions, ejection fraction [60minutes]
Ejection fraction

Secondary Outcome Measures

Plasma ketone [60 minutes]
Plasma ketone concentration

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rearsh Centre on Aging	Sherbrooke	Quebec	Canada	J1H4C4

Sponsors and Collaborators

Université de Sherbrooke
Nestlé

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Université de Sherbrooke

ClinicalTrials.gov Identifier:

NCT04580823

Other Study ID Numbers:

2020-3441

First Posted:

Oct 8, 2020

Last Update Posted:

Nov 3, 2020

Last Verified:

Nov 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Nov 3, 2020