The ketogenic diet in bipolar disorder

Not Applicable

Completed

• Conditions: Bipolar disorder; Mental and Behavioural Disorders; Bipolar affective disorder

• Registration Number: ISRCTN61613198
• Lead Sponsor: niversity of Edinburgh

Brief Summary

2023 Preprint results in https://doi.org/10.1101/2023.05.28.23290595 (added 05/06/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37814952/ (added 11/10/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-02
• Study Completion: 2023-04-08
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

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)

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified