A pilot study of the ketogenic diet in bipolar disorder
Bipolar disorder
All participants will be trialled on a low-carbohydrate, high-fat ketogenic diet for a period of 8 weeks, the first two of which will be an adaptation period. Support will be via dietary supervision to check adherence to prescribed diets, problem solve and identify any adverse effects, which will mainly occur over the phone or via email. Dietitians will provide guidance and practical support around establishing and characterising the diet, using recipe cards and planning, dietary booklets and providing advice on common problems. Prior to commencing the ketogenic diet, participants will be required to attend initial baseline assessments, including mental health and health economics questionnaires, physical parameters (height, weight, blood pressure), blood tests (for biochemistry and metabolomics) and an MRI brain scan. They will also be taught how to measure their ketone and glucose measurements and monitor their mood on a daily basis and be provided with an actigraph device to wear throughout the study.
Current participant inclusion criteria as of 29/04/2022: 1. Meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-4) diagnostic criteria for bipolar disorder for at least 1 year, assessed using the MINI Neuropsychiatric Interview 2. Clinically stable and currently euthymic, defined as 3 months with no major mood episodes (major depression lasting at least 2 weeks or hypomania/mania lasting at least 1 week), assessed using the MINI Neuropsychiatric Interview 3. Aged 18 to 70 years 4. Able to provide informed consent to take part in the study 5. Able to speak, read and understand English to a level whereby they can understand the participant information sheet (PIS) 6. Currently living in Scotland Previous participant inclusion criteria: 1. Meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-4) diagnostic criteria for bipolar disorder for at least 1 year, assessed using the MINI Neuropsychiatric Interview 2. Clinically stable and currently euthymic, defined as 3 months with no major mood episodes (major depression lasting at least 2 weeks or hypomania/mania lasting at least 1 week), assessed using the MINI Neuropsychiatric Interview 3. Aged 18 to 70 years 4. Able to provide informed consent to take part in the study 5. Able to speak, read and understand English to a level whereby they can understand the participant information sheet (PIS)
Current participant exclusion criteria as of 29/04/2022: 1. Pregnancy or breastfeeding (or those planning to become pregnant within 3 months) 2. Active substance misuse with alcohol or illicit drugs 3. Use of the ketogenic diet in the previous 2 months 4. Currently following a vegan diet 5. Admission to hospital within the past 3 months 6. Current involvement in another research study 7. Inability to complete baseline assessments 8. Liver or kidney disease 9. Cardiovascular disease 10. Severe hyperlipidaemia 11. Type 1 diabetes 12. Insulin dependent type 2 diabetes 13. Currently training for or undertaking very high energy requirement activities (as judged by the study dietitian) Previous participant exclusion criteria: 1. Pregnancy or breastfeeding (or those planning to become pregnant within 3 months) 2. Active substance misuse with alcohol or illicit drugs 3. Use of the ketogenic diet in the previous 2 months 4. Currently following a vegan diet 5. Admission to hospital within the past 3 months 6. Current involvement in another research study 7. Inability to complete baseline assessments 8. Liver or kidney disease 9. Cardiovascular disease 10. Severe hyperlipidaemia 11. Type 1 diabetes