Plain English Summary
Background and study aims
Diabetes patients have impaired energy metabolism in the heart (cardiac energetics). This can be measured as low PCr/ATP. Heart and blood vessel (cardiovascular) disease is the most common cause of death in people living with type 2 diabetes, and there is no specific treatment for cardiovascular complications in diabetes.
Ketones can improve energy metabolism in the heart. TdeltaS Ltd has developed a ketone ester drink named DeltaG® which quickly and safely elevates ketone blood levels. It is already proven to be safe as a drink in healthy humans.
The aim of this trial is to investigate whether drinking a ketone solution can increase PCr/ATP levels in the hearts of healthy volunteers. The results will guide future studies in people with diabetes or heart failure.
Who can participate?
Healthy volunteers aged 18-70 years
What does the study involve?
The participants must fast (eat no food) for 24 hours. Drinking water is allowed and encouraged during the fast. They will then undergo an MRI scan before drinking a mix of 25 ml of a ketone monoester and water. They will have another MRI scan 30 minutes after drinking the ketone solution.
What are the possible benefits and risks of participating?
The ketone drink has a very bitter taste. It is safe to drink, but may cause mild headaches and abdominal cramps. The MRI scan is not painful and doesn't use radiation, however some people experience claustrophobia while being in the scanner. There are no expected benefits of taking part.
Where is the study run from?
The Oxford Centre for Functional MRI of the Brain (UK)
When is the study starting and how long is it expected to run for?
July 2018 to August 2019
Who is funding the study?
TdeltaS Ltd.
Who is the main contact?
Dr Adrian Soto.
adrian.soto@dpag.ox.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Adrian Soto
ORCID ID
Contact details
Sherrington Building
South Parks Road
Oxford
OX1 3PT
United Kingdom
01865 282248
adrian.soto@dpag.ox.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
DG7T
Study information
Scientific title
The acute effect of a ketone monoester on cardiac PCr/ATP
Acronym
Study hypothesis
Ketone ingestion will lower cardiac phosphocreatine (PCr)/ATP ratio.
Ethics approval
Ethics approval will be sought following trial registration.
Study design
Prospective open-label basic science study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Healthy volunteers
Intervention
After consent, we will ask participants to fast for 24 hours. During this period, drinking water is allowed and encouraged. Afterwards, we will measure baseline blood ketone levels and perform a Phosphorus Magnetic Resonance Spectroscopy scan (31P MRS) which lasts around 30 minutes. Then, we will ask participants to drink a mix of 25 ml of a ketone monoester and water and repeat the 31P MRS scan and the blood ketone levels measurement. In total, participant involvement lasts around 26 hours.
Intervention type
Supplement
Phase
Drug names
Primary outcome measure
Cardiac phosphocreatine/ATP (PCr/ATP) ratio assessed using 31P MRS scan after 24 h fasting and 30 minutes after drinking the ketone monester solution
Secondary outcome measures
None
Overall trial start date
01/04/2018
Overall trial end date
01/08/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Fluent in English with no communication impairments
2. Willing and able to give informed consent for participation in the study
3. Aged 18-70 years (inclusive)
4. No known medical diagnosis
5. No prescribed medication
6. In the Investigator’s opinion, able and willing to comply with all study requirements
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
15
Participant exclusion criteria
1. Contraindication for undergoing Magnetic Resonance Imaging (MRI), such as metallic implanted devices, shrapnel or claustrophobia
2. Pregnant, lactating or planning to get pregnant
3. Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the experiment, or the participant’s ability to participate in the study.
Recruitment start date
01/08/2018
Recruitment end date
01/07/2019
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Oxford Centre for Functional MRI of the Brain
OX3 9DU
United Kingdom
Funders
Funder type
Not defined
Funder name
TdeltaS Ltd
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal
IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
01/08/2020
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list