KETO-MOOD: Ketogenic Diet for Microbiome Optimization and Overcoming Depression
Résumé de l'étude
Worldwide, up to 300 million people suffer from depressive disorders. Even among those who have access to modern mental health care, sustained remission is rare. In Europe, nearly 20% of depressed patients are considered "treatment-resistant". The significant limitations of psychopharmacological treatments make the search for new therapeutic approaches of utmost importance. There are increasing concerns about the potentially harmful effects of carbohydrate/sugar consumption habits in industrialized societies on mental health. Furthermore, the brain's utilization of glucose appears to be impaired in people with depression. A promising approach that has gained increasing attention in recent years is the ketogenic diet. This diet restricts carbohydrate intake and leads to lipolysis, producing circulating ketone bodies that serve as an additional energy source for the brain and reduce its dependence on glucose. Extensive data on the feasibility, efficacy, and safety of the ketogenic diet exist for the treatment of refractory epilepsy, primarily in pediatric populations. As a non-pharmacological approach, the ketogenic diet is generally well-tolerated and accessible. Affective disorders and epilepsies seem to share partially similar pathogenic mechanisms, and depression is a common comorbid condition in epilepsy patients. Several indications suggest the beneficial effects of the ketogenic diet in depressed individuals. However, there is a lack of rigorous clinical evidence for its utility in patients with depression. Therefore, our aim is to investigate the effects of the ketogenic diet on depression in a large patient cohort in a prospective and controlled hospital setting.
(BASEC)
Intervention étudiée
A ketogenic diet is a form of nutrition in which carbohydrate intake is severely reduced, and the focus is on a moderate intake of proteins and a high intake of healthy fats. Through this specific composition, the ketogenic diet aims to put the body's metabolism into a state where it produces more ketones. Ketones are alternative energy sources that the body makes from fatty acids instead of using glucose as the primary fuel.
In our study, we investigate the effect of the ketogenic diet on patients with depression, who will also receive regular dietary counseling in addition to standard treatment. Our goal is to examine whether the ketogenic diet can serve as a complementary measure for the treatment of depression. We want to find out if such a nutritional intervention can have positive effects on the symptoms of depression and whether it improves the effectiveness of standard treatment.
Through regular dietary counseling, we ensure that patients correctly implement the ketogenic diet and that their nutrition is balanced and meets their individual needs. This comprehensive care allows us to closely monitor and analyze the impact of the ketogenic diet on patients' mood and well-being.
By exploring the ketogenic diet as an additional therapeutic option for depression, we hope to gain new insights and potentially identify a promising approach to improving treatment outcomes for depressed patients. Our study contributes to a deeper understanding of the connections between nutrition and mental health and could potentially reveal new ways to support people with depression.
(BASEC)
Maladie en cours d'investigation
Depression, unipolar or bipolar depressive disorder
(BASEC)
- Clear diagnosis of major depression or bipolar depression according to the criteria of the ICD-10 and the ICD-11 (once approved in Switzerland) - PHQ-9 score of ≥10 (indicating at least moderate severity) - Age ≥18 years - The patient is able to give informed consent, documented by a signature - Interest in participating in a dietary intervention (BASEC)
Critères d'exclusion
- Inability to follow study procedures, e.g. due to language barriers, neurological and disruptive mental disorders, dementia - Anorexia nervosa - BMI <18.5 kg/m² - Adherence to an exclusively vegan diet - Pregnancy or breastfeeding - Current electroconvulsive therapy (ECT) - Concurrent ketamine therapy - Porphyria - Substance dependence disorder according to ICD-10 F10-F19 - Type 1 diabetes - Insulin-dependent type 2 diabetes - Contraindicated medical conditions; besides rare hereditary metabolic diseases (typically diagnosed in childhood), contraindications include acute pancreatitis, nephrolithiasis, advanced renal failure, advanced liver failure, advanced heart failure, advanced lung disease with respiratory insufficiency and concomitant use of SGLT2 inhibitors (BASEC)
Lieu de l’étude
Bâle
(BASEC)
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Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Date d'approbation du comité d'éthique
30.09.2024
(BASEC)
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