Condition category
Nutritional, Metabolic, Endocrine
Date applied
18/06/2018
Date assigned
20/06/2018
Last edited
19/06/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Sponsor information

Organisation

TdeltaS Ltd

Sponsor details

30 Upper High Street
Thame
Oxfordshire
OX9 3EZ
United Kingdom

Sponsor type

Industry

Website

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

Publication citations

Additional files

Editorial Notes