Condition category
Not Applicable
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Emerging evidence shows that calorie restriction and ketogenic diets (low carbohydrate, high fat) improve insulin resistance, weight loss and glucose metabolism. However, both low calorie and ketogenic diets are poorly tolerated. Recently, it became possible to raise blood ketone levels by providing ketones in a drink (ΔG®) without restricting food intake or carbohydrates. Its consumption for up to five days has been proven to be safe and tolerable. Confirming its consumption for longer periods is safe and well tolerated could translate into a useful new treatment for chronic diseases such as type 2 diabetes and obesity. The aim of this study is to find out whether drinking a ketone ester three times a day for 28 days is safe and well tolerated.

Who can participate?
Healthy volunteers aged 18 - 65

What does the study involve?
Participants drink a 65 ml ketone ester drink three times daily for one month. Participants are asked to keep a dietary log, to take daily glucose and blood ketone pinprick measurements, and to undergo weekly blood tests to assess the safety and tolerability of the ketone ester.

What are the possible benefits and risks of participating?
In previous safety and tolerance studies, the most reported side effects were mild nausea, abdominal distension and headache. Participants might experience moderate weight loss (less than 5% of total body weight).

Where is the study run from?
University of Oxford and the Warwickshire Institute for the Study of Diabetes, Endocrinology and Metabolism (UK)

When is the study starting and how long is it expected to run for?
October 2017 to June 2018

Who is funding the study?
TdeltaS Ltd (UK)

Who is the main contact?
Dr Luis Adrian Soto Mota

Trial website

Contact information



Primary contact

Dr Luis Adrian Soto Mota


Contact details

Department of Physiology
Anatomy and Genetics.
Sherrington Building
Parks Road
United Kingdom
+44 (0)1865 272 500

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Safety of twenty-eight-day consumption of ΔG® in healthy adults: a non-randomised study


Study hypothesis

Consuming 25 mg of a ketone ester three times a day during 28 days will be safe and well tolerated by healthy adults.

Ethics approval

South Central - Oxford B Research Ethics Committee, 07/03/2018, REC ref: 18/SC/0064

Study design

Prospective non-randomised open-label single-group study

Primary study design


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use contact details to request a participant information sheet


Consumption of a ketone ester


Consumption of a drink containing 25 mg of a ketone ester three times a day for 28 days. Participants will be asked to keep a dietary log, to take daily glucose and blood ketone pinprick measurements and to undergo weekly blood tests.

Intervention type



Drug names

Primary outcome measure

Measured at baseline and weekly after the start of the intervention until the end of participation:
1. Tolerability, measured with the reported frequency and severity of adverse effects using open questions: "Have you experienced any unpleasant symptoms in the last week?","How frequently?" and all symptoms graded as "mild", "moderate" or "severe"
2. Safety, assessed with blood samples, particularly levels of beta-hydroxybutyrate and pH

Secondary outcome measures

Measured at baseline and weekly after the start of the intervention until the end of participation:
1. Weight and body composition measured with electric bioimpedance
2. Insulin sensitivity assessed with the HOMA-IR score

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Participants must be fluent in English, have no communication impairments and should be willing and able to give informed consent for participation in the trial
2. Aged 18 – 70 (inclusive)
3. With no known medical diagnosis
4. Have had no course of medication, whether prescribed or over-the-counter, in the four weeks before the first trial dose and no individual doses in the final two weeks other than over the counter analgesics, vitamins and mineral supplements or, for females, oral contraceptives
5. Female participants of childbearing potential and male participants whose partner is of childbearing potential must be willing to ensure that they or their partner mechanical or pharmacological contraception during the trial and for 3 months thereafter
6. In the Investigator’s opinion, is able and willing to comply with all trial requirements
7. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial

Participant type

Healthy volunteer

Age group




Target number of participants


Participant exclusion criteria

1. Female participant who is pregnant, lactating or planning pregnancy during the trial
2. Significant renal or hepatic impairment
3. Scheduled elective procedures requiring general anaesthesia during the trial
4. 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 trial, or may influence the result of the trial, or the participant’s ability to participate in the trial
5. Participants who have participated in another research trial involving an investigational product in the past 12 weeks

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University of Oxford
Department of Physiology, Anatomy and Genetics Sherrington Building Parks Road
United Kingdom

Trial participating centre

Warwickshire Institute for the Study of Diabetes, Endocrinology and Metabolism
University Hospital Clifford Bridge Road
United Kingdom

Sponsor information


TdeltaS Ltd

Sponsor details

30 Upper High Street
United Kingdom

Sponsor type




Funder type


Funder name

TdeltaS Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Planned publication of the study results in a high-impact peer-reviewed journal in August 2019. The study protocol and statistical analysis plan will be available on request from Dr Adrian Soto Mota (

IPD sharing statement
Access will be granted to authorised representatives from the Sponsor, host institution and the regulatory authorities to permit trial-related monitoring, audits and inspections. To request it, contact Professor Kieran Clarke (

Intention to publish date


Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

07/03/2018: Ethics approval details added.