HealthyNCT04580823
Heart and Kidney Ketones Metabolism
A study testing Fasting with exogenous ketone salt supplement and Post-Prandial with exogenous ketone salt supplement in people with Healthy, run by Université de Sherbrooke at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 45 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fasting with exogenous ketone salt supplement and Post-Prandial with exogenous ketone salt supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 15 Oct 2020to 15 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 45 and 64
- Generally Healthy
- BMI between 18.5 and 27
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exogenous Ketone Salt on Heart and Kidney Ketone Metabolism Measured by Positron Emission Tomography
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Fasting with exogenous ketone salt supplement, Post-Prandial with exogenous ketone salt supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting with exogenous ketone salt supplementDietary supplement
Also called 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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Fasting without exogenous ketone salt supplement |
| Fasting with exogenous ketone salt supplement | Experimental | Fasting with exogenous ketone salt supplement Receives: Dietary Supplement: Fasting with exogenous ketone salt supplement |
| Post-Prandial with exogenous ketone salt supplement | Experimental | Post-Prandial with exogenous ketone salt supplement Receives: Dietary Supplement: Post-Prandial with exogenous ketone salt supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
11C-Acetoacetate Heart Ketone uptake
Heart ketone uptake measured by PET scan
Measured: 60 minutes
11C-Acetoacetate Kidney ketone uptake
Kidney ketone uptake measured by PET scan
Measured: 60 minutes
Cardiac Functions, telediastolic volume
telediastolic volume
Measured: 60 minutes
Cardiac Functions, telesystolic volume
telesystolic volume
Measured: 60 minutes
Cardiac functions, ejection fraction
Ejection fraction
Measured: 60minutes
Secondary outcomes (1)
Plasma ketone
Plasma ketone concentration
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start15 Oct 2020
- Primary completion15 Aug 2022
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant will have to do the 3 acute interventions
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Société des Produits Nestlé (SPN)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580823
- Sponsor's protocol ID
- 2020-3441
- Status last verified
- Jul 2023
- First submitted
- 7 Jul 2020
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exogenous Ketone Salt on Heart and Kidney Ketone Metabolism Measured by Positron Emission Tomography
- ClinicalTrials.gov ID
- NCT04580823
- Acronym / sponsor ID
- 2020-3441
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Société des Produits Nestlé (SPN)
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Each participant will have to do the 3 acute interventions
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Fasting without exogenous ketone salt supplement |
| Fasting with exogenous ketone salt supplement | Experimental | Dietary Supplement: Fasting with exogenous ketone salt supplementFasting with exogenous ketone salt supplement |
| Post-Prandial with exogenous ketone salt supplement | Experimental | Dietary Supplement: Post-Prandial with exogenous ketone salt supplementPost-Prandial with exogenous ketone salt supplement |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged between 45 and 64
- Generally Healthy
- BMI between 18.5 and 27
Key exclusion criteria (13 listed)
- All drugs taken on a daily basis
- Diabetes or pre-diabetes
- Digestive dysfunction
- Pregnancy or lactation
- Allergy to the supplement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fasting with exogenous ketone salt supplementAlso: Post-Prandial with exogenous ketone salt supplementParticipants will have to take 2 doses of supplement, one 75 minutes before the scan and one 30 minutes before the scan. | Dietary supplement | Fasting with exogenous ketone salt supplement |
| Post-Prandial with exogenous ketone salt supplementParticipants 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. | Dietary supplement | Post-Prandial with exogenous ketone salt supplement |
Primary outcome
11C-Acetoacetate Heart Ketone uptake
Time frame: 60 minutes
Heart ketone uptake measured by PET scan
11C-Acetoacetate Kidney ketone uptake
Time frame: 60 minutes
Kidney ketone uptake measured by PET scan
Cardiac Functions, telediastolic volume
Time frame: 60 minutes
telediastolic volume
Cardiac Functions, telesystolic volume
Time frame: 60 minutes
telesystolic volume
Cardiac functions, ejection fraction
Time frame: 60minutes
Ejection fraction
1 secondary outcome
Plasma ketone
Time frame: 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting with exogenous ketone salt supplement and Post-Prandial with exogenous ketone salt supplement in people with Healthy, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
11C-Acetoacetate Heart Ketone uptake (time frame: 60 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.