Does a ketone drink improve cardiac energetics?
| ISRCTN | ISRCTN15716557 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15716557 |
| Secondary identifying numbers | DG7T |
- Submission date
- 18/06/2018
- Registration date
- 20/06/2018
- Last edited
- 19/06/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
Sherrington Building
South Parks Road
Oxford
OX1 3PT
United Kingdom
| Phone | 01865 282248 |
|---|---|
| adrian.soto@dpag.ox.ac.uk |
Study information
| Study design | Prospective open-label basic science study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | The acute effect of a ketone monoester on cardiac PCr/ATP |
| Study objectives | Ketone ingestion will lower cardiac phosphocreatine (PCr)/ATP ratio. |
| Ethics approval(s) | Ethics approval will be sought following trial registration. |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/04/2018 |
| Completion date | 01/08/2019 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 15 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 01/08/2018 |
| Date of final enrolment | 01/07/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
United Kingdom
Sponsor information
Industry
30 Upper High Street
Thame, Oxfordshire
OX9 3EZ
United Kingdom
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 01/08/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
