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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Use of ketogenic metabolic therapy in individuals with depression and anxiety
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This study aims to deliver an online group ketogenic metabolic therapy (KMT) program to community participants with varying levels of depression and anxiety and evaluate the clinical impact via measurable improvements in mental health outcomes over 7 time points: 0 (baseline), 4, 8, 12, 16, 20 and 24 weeks. The plan is to integrate KMT into an existing care delivery model. The current model includes psychoeducation and ongoing professional and community support, which can then be implemented into real-world clinical settings. There is a need to support individuals to learn and effectively apply the intervention, but also to sustain it long term if they experience improvements in their mental health symptoms and overall well-being. Previous studies have ranged from 6-16 weeks, with only one study extending up to 248 days, suggesting a need for a two-phase care model: (1) education and implementation, and (2) long-term lifestyle support. Prior research recommends investigating KMT in a remote care setting, focused on mental health symptoms monitoring, dietary adjustments based on ketone levels and frequent coaching over a period of at least 12 weeks. Although individual support is ideal, scalability needs a remote, cost-effective approach to reach individuals both geographically far and wide, as well as those who are unable to leave their homes due to symptom severity.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. BMI <18.5 kg/m²2. Recent ECT or ketamine therapy3. Active suicidal ideation with intent (captured at baseline and given support information)4. Developmental delays, neurological conditions (e.g., dementia, ASD level 2+), diagnosis of chronic fatigue syndrome (CFS), coagulation disorders, serious food allergies, restrictive diets (e.g., vegetarian or vegan), or those unable to comply with study protocols5. No recent or current ketogenic or low-carbohydrate diet (past three months), drug/alcohol dependence (last 6 months), or planned major surgery during study6. Current or recent use (past 6 months) of GLP-1 medications7. Use of incompatible medications (e.g., SGLT2 inhibitors, anticoagulants)8. Refusal of dietary, monitoring, or testing requirements will also exclude participation9. Involvement in any other research study10. Detailed recommendations on medical contraindications will also be followed as per previous research trials. See a comprehensive list below:10.1. Myalgic Encephalomyelitis (ME)10.2. Chronic Fatigue Syndrome (CFS)10.3. Taking Topamax, Zonisamide or Valproate/ Depakote10.4. Acute or history of Pancreatitis10.5. Liver Failure10.6. Porphyria10.7. Genetic disorders of fatty acid oxidation10.8. Glycogen storage disease type 1 (Von Gierke’s disease)10.9. Succinyl-CoA:3-ketoacid CoA transferase deficiency10.10. Carnitine deficiency (primary)10.11. Carnitine palmitoyltransferase deficiency (CPT I/II)10.12. Carnitine-acylcarnitine translocase deficiency10.13. Mitochondrial fatty acid beta oxidation disorders10.14. Short-chain acyl dehydrogenase deficiency10.15. Medium-chain acyl dehydrogenase deficiency10.16. Long-chain acyl dehydrogenase deficiency10.17. Very long-chain acyl dehydrogenase deficiency10.18. Medium-chain 3-hydroxyacyl-coenzyme A deficiency10.19. Long-chain 3-hydroxyacyl-coenzyme A deficiency10.20. Pyruvate carboxylase deficiency10.21. Epilepsy10.22. Cardiovascular disease10.23. Cholecystectomy10.24. Renal failure10.25. Nephrolithiasis10.26. Osteopenia or osteoporosis10.27. Hyperlipidaemia10.28. History of cerebrovascular disease10.29. History of anorexia10.30. Severe gastroesophageal reflux
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Erin
Bellamy
e.l.bellamy@uel.ac.uk
The study is sponsored by University of East London and funded by Baszucki Group.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.