Condition category
Not Applicable
Date applied
28/12/2017
Date assigned
10/01/2018
Last edited
07/03/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
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
adrian.soto@dpag.ox.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Luis Adrian Soto Mota

ORCID ID

http://orcid.org/0000-0002-9173-7440

Contact details

Department of Physiology
Anatomy and Genetics.
Sherrington Building
Parks Road
Oxford
OX1 3PT
United Kingdom
+44 (0)1865 272 500
adrian.soto@dpag.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DELTAGHP2018

Study information

Scientific title

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

Acronym

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

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Other

Patient information sheet

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

Condition

Consumption of a ketone ester

Intervention

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

Supplement

Phase

Drug names

Primary outcome measures

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

01/10/2017

Overall trial end date

30/06/2018

Reason abandoned

Eligibility

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

Adult

Gender

Both

Target number of participants

30

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

01/02/2018

Recruitment end date

01/06/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Oxford
Department of Physiology, Anatomy and Genetics Sherrington Building Parks Road
Oxford
OX1 3PT
United Kingdom

Trial participating centre

Warwickshire Institute for the Study of Diabetes, Endocrinology and Metabolism
University Hospital Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Sponsor information

Organisation

TdeltaS Ltd

Sponsor details

30 Upper High Street
Thame
OX9 3EZ
United Kingdom

Sponsor type

Industry

Website

http://tdeltas.com/

Funders

Funder type

Industry

Funder name

TdeltaS Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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 (adrian.soto@dpag.ox.ac.uk).

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 (info@tdeltas.com).

Intention to publish date

01/08/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

07/03/2018: Ethics approval details added.