Randomised Controlled Trial of a Ketogenic Diet for Bipolar Depression (“Keto- BD”).

Emerging evidence suggests that a metabolic/nutritional approach - specifically a ketogenic diet - may be effective in treating depressive symptoms in bipolar disorder. Ketogenic diets are low in carbohydrate and high in fat and cause mitochondria in the brain to make use of ketones rather than glucose as a primary source of energy (as such, they may represent a more efficient mode of energy delivery to brain tissue). We recently completed a pilot study of the ketogenic diet in euthymic people with bipolar disorder. This intervention was feasible and well tolerated and was associated with both improved mental health and metabolic outcomes. The goals of the "Keto-BD" trial are: a) to determine the efficacy of a ketogenic diet in comparison to the NHS Eat Well diet for bipolar depression; b) To assess whether changes in Magnetic Resonance Spectroscopy markers of brain energetics represent a mechanism of action of the ketogenic diet; c) To assess the healthcare resource use consequences and associated costs of the ketogenic diet intervention; and d) To assess the acceptability, feasibility and fidelity of the ketogenic diet intervention intervention. This study represents the first adequately powered randomized controlled trial of the ketogenic diet for bipolar depression.