Ketogenic Diet for Treatment-Resistant Depression: Dietary Interventions for MEntal Health Study (DIME)

Launched by UNIVERSITY OF OXFORD · Oct 13, 2023

Keywords

ClinConnect Summary

The DIME study is researching whether a ketogenic diet, which is high in fats and very low in carbohydrates, can help people who have treatment-resistant depression. This means the study is focused on individuals aged 18 to 65 who are currently taking antidepressant medication but haven’t found relief from their symptoms after trying at least two different types of antidepressants. The goal is to see if following this special diet, combined with ongoing treatment, can improve their depression symptoms over six weeks.

If you or someone you know is interested in participating, you would need to have been diagnosed with depression and currently be on an antidepressant for at least four weeks. You would also need to be willing to follow specific dietary guidelines. Participants will receive either a ketogenic meal plan with support from a nutrition counselor or guidance on a healthier diet with more vegetables. Throughout the study, participants will answer questions about their mood and well-being to help researchers understand the impact of the diet on their depression. It's important to note that individuals with certain medical conditions or dietary restrictions may not be eligible for the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged 18-65 years
• • Have been diagnosed with depression
• • Currently on an antidepressant medication for a period of 4-weeks or longer
• • Have tried 2 or more antidepressant treatment trials of adequate dose and duration within the current depressive episode to which they did not fully respond. An adequate treatment trial is defined as at least 4 weeks of a medication at a minimum National Institute for Health and Care Excellence (NICE) approved dose
• • With a Patient Health Questionnaire-9 (PHQ-9) total score greater than or equal to 15 at baseline
• • Able to understand and be willing to adhere to the demands of the study
• • Provision of written informed consent
• • Have access to a tablet/computer for online assessments, follow-ups with the registered dietitian, and able to attend appointments for assessments and treatment and adhere to study procedures
• • Have both a fridge and a freezer at home
• • Complete all baseline assessments
• Exclusion Criteria:
• • Currently following a low carbohydrate or ketogenic diet
• • Currently following a vegan or vegetarian diet as these diets are more challenging to accommodate in a Ketogenic Diet and adding vegetables in the control group is unlikely to be seen as helpful.
• • Currently receiving, or have received, in-patient psychiatric treatment or electroconvulsive therapy (electric shock to the brain under brief general anaesthetic) within the past year, or scheduled to receive such treatment during the study
• • Currently using St John's wort or other remedies for depression that were bought without a doctor's prescription
• • Currently have suicidal ideation with intent\* or attempted suicide within the past two months
• • Ever had an eating disorder, bipolar disorder, schizophrenia, or psychosis
• • Have substance use or alcohol dependence
• • Have epilepsy
• • Have serious food allergies (experiencing food hypersensitivity that leads to anaphylaxis or other severe symptoms, which may require hospitalisation or are life-threatening) or otherwise require a special diet that cannot be accommodated within a KD such as phenylketonuria or lactose intolerance
• • Treated with insulin, sulfonylureas, Glucagon-like peptide-1 (GLP-1) agonists, or Sodium-glucose co-transporter-2 (SGLT2) inhibitors
• • Women who are pregnant, planning pregnancy in the next three months, or breastfeeding
• • Have a body mass index (BMI) of \<18.5 kg/m2
• • Have unstable or severe medical conditions (e.g., cancer, cardiovascular, renal, lung, psychiatric, or bleeding disorders, diabetes, etc.), currently receiving cancer treatment except hormonal treatment for breast cancer or non-melanoma skin cancer treatment
• • Have gallstones, renal tubular acidosis, kidney stones, small bowel malabsorption or a history of pancreatitis
• • Have scheduled a major surgery in the next 3 months
• • Taking part in other studies that may compromise this study or this study may compromise the other study/ies
• • Have read the trial protocol or the clinical trial registration information and therefore are unblinded
• • Live in the same household as another participant in the trial
• • Not able to complete the online task with a tablet/computer
• • Not willing to provide saliva, urine and stool samples