Heart and Kidney Ketones Metabolism

NCT ID: NCT04580823

Last Updated: 2023-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-15

Study Completion Date

2023-01-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Each participant will have to do the 3 acute interventions
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Control

Fasting without exogenous ketone salt supplement

Group Type NO_INTERVENTION

No interventions assigned to this group

Fasting with exogenous ketone salt supplement

Fasting with exogenous ketone salt supplement

Group Type EXPERIMENTAL

Fasting with exogenous ketone salt supplement

Intervention Type DIETARY_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

Post-Prandial with exogenous ketone salt supplement

Group Type EXPERIMENTAL

Post-Prandial with exogenous ketone salt supplement

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Post-Prandial with exogenous ketone salt supplement

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role collaborator

Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rearsh Centre on Aging

Sherbrooke, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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2020-3441

Identifier Type: -

Identifier Source: org_study_id

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