Safety of twenty-eight-day consumption of ΔG® in healthy adults and type 2 diabetes patients
| ISRCTN | ISRCTN12401551 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12401551 |
| Secondary identifying numbers | DELTAGHP2018 |
- Submission date
- 28/12/2017
- Registration date
- 10/01/2018
- Last edited
- 27/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Current plain English summary as of 26/10/2018:
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 - 70 or people with type 2 diabetes aged 18-70. The study is currently only recruiting people with type 2 diabetes and is no longer recruiting healthy volunteers.
What does the study involve?
For healthy volunteers:
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.
For people with type 2 diabetes:
The study will involve 7 weekly visits either to the Department of Physiology, Anatomy and Genetics (DPAG) or to the Warwickshire Institute for the Study of Diabetes, Endocrinology and Metabolism (WISDEM) over approximately six weeks. Participants will drinking three times daily for 28 days a 65 ml drink containing 25 mg of ΔG® and 120 calories. It has a bitter taste and participants will get to taste it before enrolling. Participants will also be asked to wear a continuous glucose monitor for 6 weeks. There will be a weekly collection of blood samples and a urine dipstick test.
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
Previous 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
Contact information
Public
Department of Physiology, Anatomy and Genetics.
Sherrington Building
Parks Road
Oxford
OX1 3PT
United Kingdom
 ORCID ID |
0000-0002-9173-7440 |
|---|---|
| Phone | +44 (0)1865 272 500 |
| adrian.soto@dpag.ox.ac.uk |
Study information
| Study design | Prospective non-randomised open-label single-group study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Safety of twenty-eight-day consumption of ΔG® in healthy adults and type 2 diabetes patients: 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(s) | South Central - Oxford B Research Ethics Committee, 07/03/2018, REC ref: 18/SC/0064 |
| 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 |
| 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 study start date | 01/10/2017 |
| Overall study end date | 30/06/2020 |
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 | 30 |
| Total final enrolment | 21 |
| Participant inclusion criteria | Current participant inclusion criteria as of 26/10/2018: This study is currently only recruiting people with type 2 diabetes. People with type 2 diabetes: 1. Type2 diabetes patients who don’t use or need insulin and who have had the same treatment for the last 6 months. Confirmation of eligibility from your GP will be requested. 2. Fluent in English 3. Males, or females using hormonal birth control if sexually active 4. Aged 18-70 Healthy volunteers (not currently open to recruitment): 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 Previous 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 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 | 30/04/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Sherrington Building
Parks Road
Oxford
OX1 3PT
United Kingdom
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Sponsor information
Industry
30 Upper High Street
Thame
OX9 3EZ
United Kingdom
| Website | http://tdeltas.com/ |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/08/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | 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). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 20/05/2021 | 27/02/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
27/02/2023: Publication reference and total final enrolment added.
26/10/2018: The following changes have been made to the trial record:
1. The public title has been changed from "Safety of twenty-eight-day consumption of ΔG® in healthy adults" to "Safety of twenty-eight-day consumption of ΔG® in healthy adults and type 2 diabetes patients"
2. The scientific title has been changed from "Safety of twenty-eight-day consumption of ΔG® in healthy adults: a non-randomised study" to "Safety of twenty-eight-day consumption of ΔG® in healthy adults and type 2 diabetes patients: a non-randomised study"
3. The overall trial end date has been changed from 30/06/2018 to 30/06/2020
4. The participant inclusion criteria have been updated
5. The recruitment end date has been changed from 01/06/2018 to 30/04/2020
6. The plain English summary has been updated
7. The intention to publish date has been changed from 01/08/2019 to 01/08/2020
07/03/2018: Ethics approval details added.
