Safety of twenty-eight day consumption of ΔG® in healthy adults (V1)
Research type
Research Study
Full title
Safety of twenty-eight-day consumption of ΔG® in healthy adults
IRAS ID
240942
Contact name
Rhys Evans
Contact email
Sponsor organisation
TdeltaS Ltd
Clinicaltrials.gov Identifier
ISRCTN12401551, ISRCTN registry
Duration of Study in the UK
0 years, 4 months, 27 days
Research summary
Is drinking a ketone ester three times a day for 28 days safe and well tolerated?
Why?
Emerging evidence shows that calorie restriction and ketogenic diets (low carbohydrate, high fat) improve insulin resistance, weight loss and glucose metabolism. However, both hypo-caloric, 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 regular consumption for up to five days has been proven to be safe and tolerable.
How is it of relevance and importance to patients and public?
Confirming its consumption for longer periods is safe and well tolerated could translate into a useful and novel treatment for chronic diseases such as type two diabetes and obesity.Who would be eligible?
Healthy volunteers aged 18 - 70 years old.Where?
The Department of Physiology, Anatomy and Genetics (DPAG) and the Warwickshire Institute for the Study of Diabetes, Endocrinology and Metabolism (WISDEM).How?
By drinking a 65 ml ketone ester drink three times daily during one month. Participants will be asked to keep a dietary log, to take ten random glucose and blood ketone pinprick measurements and to undergo weekly blood tests.REC name
South Central - Oxford B Research Ethics Committee
REC reference
18/SC/0064
Date of REC Opinion
7 Mar 2018
REC opinion
Further Information Favourable Opinion