NCT04580823

Brief Summary

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

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

October 15, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2023

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

1.8 years

First QC Date

July 7, 2020

Last Update Submit

July 18, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

  • 11C-Acetoacetate Heart Ketone uptake

    Heart ketone uptake measured by PET scan

    60 minutes

  • 11C-Acetoacetate Kidney ketone uptake

    Kidney ketone uptake measured by PET scan

    60 minutes

  • Cardiac Functions, telediastolic volume

    telediastolic volume

    60 minutes

  • Cardiac Functions, telesystolic volume

    telesystolic volume

    60 minutes

  • Cardiac functions, ejection fraction

    Ejection fraction

    60minutes

Secondary Outcomes (1)

  • Plasma ketone

    60 minutes

Study Arms (3)

Control

NO INTERVENTION

Fasting without exogenous ketone salt supplement

Fasting with exogenous ketone salt supplement

EXPERIMENTAL

Fasting with exogenous ketone salt supplement

Dietary Supplement: Fasting with exogenous ketone salt supplement

Post-Prandial with exogenous ketone salt supplement

EXPERIMENTAL

Post-Prandial with exogenous ketone salt supplement

Dietary Supplement: Post-Prandial with exogenous ketone salt supplement

Interventions

Fasting with exogenous ketone salt supplementDIETARY_SUPPLEMENT

Participants will have to take 2 doses of supplement, one 75 minutes before the scan and one 30 minutes before the scan.

Also known as: Post-Prandial with exogenous ketone salt supplement
Fasting with exogenous ketone salt supplement
Post-Prandial with exogenous ketone salt supplementDIETARY_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.

Post-Prandial with exogenous ketone salt supplement

Eligibility Criteria

Age45 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rearsh Centre on Aging

Sherbrooke, Quebec, J1H4C4, Canada

Location

MeSH Terms

Interventions

Postprandial Period

Intervention Hierarchy (Ancestors)

Digestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Each participant will have to do the 3 acute interventions
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2020

First Posted

October 8, 2020

Study Start

October 15, 2020

Primary Completion

August 15, 2022

Study Completion

January 15, 2023

Last Updated

July 19, 2023

Record last verified: 2023-07

Locations

CA(1)