Use of ketogenic metabolic therapy in individuals with depression and anxiety Mental and Behavioural Disorders
Conditions
Interventions
The IKRT Group Metabolic Mental Health (MMH) Program is a fully remote, structured ketogenic metabolic therapy (KMT) intervention delivered via GDPR-compliant platforms (PracticeBetter and Zoom). The
1.5:1–2:1 ratio) matched to individual energy requirements, ketogenic food lists, recipes, educational resources, and access to a moderated private online community. All participants will prepare thei
Sponsors
University of East London
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 13/04/2026: 1. Adults (18 - 80) in the UK 2. BMI >18.5 kg/m² 3. Participants are eligible for inclusion if they meet one of two criteria: (1) a formal diagnosis of depression, anxiety, or both (with or without comorbid ADHD), alongside a score of =10 on the Patient Health Questionnaire-9 (PHQ-9) and/or the Generalized Anxiety Disorder-7 (GAD-7); or (2) no formal psychiatric diagnosis other than ADHD, alongside a score of =10 on the PHQ-9 and/or GAD-7. 4. May be on stable psychiatric medication (excluding clozapine >550 mg) and must have professional clinical oversight for medications (via a psychiatrist or general practitioner) 5. Non-diabetic or pre-diabetic 6. Clinically stable (no hospitalisation past 3 months) 7. Not pregnant, nursing, or planning to become pregnant within the next 6 months 8. Able to give informed consent in English 9. Must be capable of completing digital tracking (diet/symptom diaries, questionnaires), attending all sessions, and using applications on a compatible smartphone Previous key inclusion criteria: 1. Adults (18 - 80) in the UK 2. BMI >18.5 kg/m² 3. Formal diagnoses of depression and anxiety, or with scale scores of at least moderate levels of depression and anxiety (PHQ-9 >10, GAD-7 >10) 4. May be on stable psychiatric medication (excluding clozapine >550 mg) and must have professional clinical oversight for medications (via a psychiatrist or general practitioner) 5. Non-diabetic or pre-diabetic 6. Clinically stable (no hospitalisation past 3 months) 7. Not pregnant, nursing, or planning to become pregnant within the next 6 months 8. Able to give informed consent in English 9. Must be capable of completing digital tracking (diet/symptom diaries, questionnaires), attending all sessions, and using applications on a compatible smartphone
Exclusion criteria
Exclusion criteria: 1. BMI <18.5 kg/m² 2. Recent ECT or ketamine therapy 3. 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 protocols 5. No recent or current ketogenic or low-carbohydrate diet (past three months), drug/alcohol dependence (last 6 months), or planned major surgery during study 6. Current or recent use (past 6 months) of GLP-1 medications 7. Use of incompatible medications (e.g., SGLT2 inhibitors, anticoagulants) 8. Refusal of dietary, monitoring, or testing requirements will also exclude participation 9. Involvement in any other research study 10. 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/ Depakote 10.4. Acute or history of Pancreatitis 10.5. Liver Failure 10.6. Porphyria 10.7. Genetic disorders of fatty acid oxidation 10.8. Glycogen storage disease type 1 (Von Gierke’s disease) 10.9. Succinyl-CoA:3-ketoacid CoA transferase deficiency 10.10. Carnitine deficiency (primary) 10.11. Carnitine palmitoyltransferase deficiency (CPT I/II) 10.12. Carnitine-acylcarnitine translocase deficiency 10.13. Mitochondrial fatty acid beta oxidation disorders 10.14. Short-chain acyl dehydrogenase deficiency 10.15. Medium-chain acyl dehydrogenase deficiency 10.16. Long-chain acyl dehydrogenase deficiency 10.17. Very long-chain acyl dehydrogenase deficiency 10.18. Medium-chain 3-hydroxyacyl-coenzyme A deficiency 10.19. Long-chain 3-hydroxyacyl-coenzyme A deficiency 10.20. Pyruvate carboxylase deficiency 10.21. Epilepsy 10.22. Cardiovascular disease 10.23. Cholecystectomy 10.24. Renal failure 10.25. Nephrolithiasis 10.26. Osteopenia or osteoporosis 10.27. Hyperlipidaemia 10.28. History of cerebrovascular disease 10.29. History of anorexia 10.30. Severe gastroesophageal reflux
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depression and anxiety measured using the Patient Health Questionnaire-9 (PHQ-9), General Anxiety Disorder-7 (GAD-7) and Depression Anxiety Stress Scales – Short Form (DASS-21) at baseline, 4 , 8 , 12 , 16 , 20 and 24 weeks;Participant compliance measured using the keto-mojo device at daily, across 18 of 24 weeks;Binge eating, positive and negative affect, mental well-being, self-compassion, and PTSD symptoms measured using the Binge-Eating Scale (BES), Positive and Negative Affect Schedule (PANAS) , Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), Self-Compassion Scale (SCS) and the PTSD Checklist for DSM-5 (PCL-5) at baseline, 4 , 8 , 12 , 16 , 20 and 24 weeks;Attrition rate measured using data collected on the number of participants who consent to participate who remain in the study until the end of the study at 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Glucose/ketone ratio measured using the keto-mojo device at daily, across 18 of 24 weeks | — |
Countries
England, United Kingdom
Contacts
Public ContactErin Bellamy
Outcome results
None listed