The influence of ketones on immune cells in healthy adults
Research type
Research Study
Full title
Investigation into the immunoregulation induced by ketogenic dietary supplements in healthy adults
IRAS ID
260489
Contact name
David J Roberts
Contact email
Sponsor organisation
Clinical Trials and Research Governance, University of Oxford
Duration of Study in the UK
1 years, 1 months, 7 days
Research summary
Recent studies in the clinic have shown that some cells from the immune system that circulate in low numbers in healthy people can improve survival following bone marrow transplantation. These cells, called regulatory T cells (Tregs), can prevent harmful inflammatory responses.
There is increasing evidence that ketones have important immunomodulatory effects. Ketones may affect the number of Tregs within the graft of cells given to the patient in a bone marrow transplantation. Furthermore, ketones may boost Tregs in the patient receiving the graft. Either approach could improve survival, decrease transplant related complications and improve clinical outcome. However, a ketogenic diet (high fat, low carbohydrates) requires high fat intake and strict carbohydrate restriction to raise endogenous ketone levels. This makes the regimen unpleasant, with resultant constipation and non-compliance. Moreover, fasting to raise ketone levels is impractical.
Therefore, we would employ a novel, yet safe and tolerable, ketone drink, such as ΔG®, to raise endogenous ketone levels. The objective of this study is to measure the Tregs in relation to all T cells and to compare this to levels of ketones (D-β-hydroxybutyrate and other substances that may become relevant) in plasma. The information from this study will provide data to help set up clinical trials to improve Treg content within grafts and thus improve outcomes of bone marrow transplantation. It is possible to measure Treg: total T cell ratios by antibodies and also by DNA based methods. We will use both methods.
We would recruit non-patient volunteers to take part in this study, which would last 6 weeks (4 weeks of intervention plus 2 weeks of follow-up).
It would be an important step towards characterising the role of this energy component in reducing the activity of harmful inflammatory immune cells in stem cell grafts to improve clinical outcomes following bone marrow transplantation.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
20/EM/0017
Date of REC Opinion
1 Oct 2020
REC opinion
Further Information Favourable Opinion