Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder

Официальное название

A Randomized Controlled Clinical Trial of Ketogenic and Nutritional Interventions for Brain Energy Metabolism and Psychiatric Symptoms in First Episode Bipolar Disorder.

Обзор

This is a randomized, controlled clinical trial to assess the effects of the ketogenic diet in combination with treatment as usual on brain energy metabolism and psychiatric symptoms in individuals with first episode bipolar disorder and schizoaffective disorder.

Подробное описание

Several lines of evidence show energy metabolism and redox dysregulation in bipolar disorder and psychotic disorders. Ketogenic interventions targeting energy metabolism are promising therapeutic approaches to improve mood and psychosis in bipolar disorder and other psychotic disorders. Early intervention is also critical to helping people achieve their goals for recovery after a first episode. Investigators aim to use multimodal imaging and metabolic measures to study the effects of a ketogenic diet intervention on energy metabolism and psychiatric symptoms in individuals with first episode bipolar disorder and schizoaffective disorder. This 12-week randomized controlled trial will assess the benefits of a ketogenic diet in combination with treatment as usual compared to a standard diet. Investigators will measure the effects of nutritional ketosis on brain redox and energy metabolism and other neurometabolic markers using magnetic resonance spectroscopy. Furthermore, investigators will measure the effects of the ketogenic diet on mood and psychotic symptoms and metabolic measures such as insulin resistance.

Вмешательства

• Другое Ketogenic diet
  The ketogenic diet (KD) is a normo-caloric diet composed of high-fat, low carbohydrate, and adequate protein intake. The KD will consist of 3 meals a day plus snacks, targeting 75-80% fat, 13-18% protein, 7% carbohydrates.
• Другое Dietary Guidelines for Americans
  Dietary Guidelines for Americans diet is a normo-caloric diet consisting of 3 meals a day plus snacks, emphasizing nutrient dense foods to meet food group needs (85% of calories), and limits foods and beverages higher in added sugars and saturated fat (15% of calories).

Первичные конечные точки

• Change in brain redox nicotinamide adenine dinucleotide metabolites ratio (NAD+/NADH) [Срок оценки: 12 weeks]
• Change in brain creatine kinase forward reaction rate (kf) [Срок оценки: 12 weeks]
• Change in insulin resistance [Срок оценки: 12 weeks]
• Change in psychotic symptoms [Срок оценки: 12 weeks]
• Change in depressive symptoms [Срок оценки: 12 weeks]
• Change in mania symptoms [Срок оценки: 12 weeks]
• Change in Clinical Global Impression (CGI) Scale [Срок оценки: 12 weeks]

Вторичные конечные точки (12)

• Change in body weight [Срок оценки: 12 weeks]
• Change in glycated hemoglobin (Hemoglobin A1c) level [Срок оценки: 12 weeks]
• Change in triglyceride levels [Срок оценки: 12 weeks]
• Change in low-density lipoprotein (LDL) levels [Срок оценки: 12 weeks]
• Change in high-density lipoprotein (HDL) levels [Срок оценки: 12 weeks]
• Change in high-sensitivity C-reactive protein (hs-CRP) levels [Срок оценки: 12 weeks]
• Change in brain gamma-aminobutyric acid (GABA) concentration [Срок оценки: 12 weeks]
• Change in brain glutamate metabolite concentration [Срок оценки: 12 weeks]
• Change in brain glutathione (GSH) [Срок оценки: 12 weeks]
• Change in brain Phosphocreatine (PCr) [Срок оценки: 12 weeks]
• Change in brain pH [Срок оценки: 12 weeks]
• Change in brain inorganic phosphate concentration [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• Between the ages of 18 and 45.
• Ability to adhere to study diets.
• Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnosis of bipolar I disorder or schizoaffective disorder with onset of illness in the last 7 years.
• Must have a stable psychiatric disorder with no change in psychiatric medications within the past 2 weeks of screening
• Must not be expected to require addition of any new psychiatric medications during the 12-week duration of the study.

Критерии исключения

• Unable to sign informed consent
• Contraindication to magnetic resonance (MR) scan (including claustrophobia)
• Unstable medical illness (including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease)
• Current DSM-5 substance use disorder
• Currently pregnant, nursing, or of childbearing potential and not using a medically accepted means of contraception
• Have a body weight of over 350 lbs or a body mass index (BMI) <20
• Score above 15 on the Young Mania Rating Scale (YMRS)
• History of significant head injury
• Current cancer diagnosis
• Current diagnosis of type 1 or type 2 Diabetes Mellitus
• History of gastric bypass surgery or any weight loss surgery
• Concomitant treatment with Propofol
• Familial hypercholesterolemia

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• McLean Hospital — Belmont

Идентификаторы

NCT: NCT06221852 · 2023P002849

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗