The ketogenic diet in bipolar disorder
Research type
Research Study
Full title
A pilot study of the ketogenic diet in bipolar disorder
IRAS ID
306939
Contact name
Harry Campbell
Contact email
ISRCTN Number
ISRCTN:61613198
Duration of Study in the UK
0 years, 11 months, 21 days
Research summary
Bipolar disorder (BD) is a major lifelong mental health condition, which significantly impacts on the quality of life of sufferers. Our current understanding of how it develops is poor, and as such treatments are not always effective. There is some evidence that the ketogenic diet (KD), which is low in carbohydrate and high in fat, may be an effective treatment for BD, and some patients already follow this diet. To date there has been no clinical trial of the KD in BD.
We will pilot the introduction of a KD for 8 weeks in 25 patients with BD, who are stable in mood, aged 18-70, and able to provide informed consent. We aim to find out how easy it is to do this, the main challenges, and how to address these. Acceptability of the intervention (and pre and post measurements) will be assessed, looking at how many people remain on the diet, what adverse effects they experience, and what support they require in sticking to the diet. This will provide feasibility information that will inform the design a future clinical trial.
Participants will have tests performed before starting the diet and after 8 weeks, at a clinical research facility. These will include questionnaires relating to mental health and physical measurements such as their blood pressure. Blood tests and brain imaging will also be performed to look at specific markers which may change on the KD. This will help with understanding how the diet might work. Participants will also monitor their ketone and glucose levels, daily mood state and diet whilst on the KD, and wear a wrist device to record sleep and activity.
REC name
South East Scotland REC 02
REC reference
22/SS/0007
Date of REC Opinion
24 Jan 2022
REC opinion
Favourable Opinion