Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ketogenic diet, Dietary Guidelines for Americans.
- Who it may be relevant to
- Registry conditions: Bipolar I Disorder, Psychosis, Schizoaffective Disorder. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized Controlled Clinical Trial of Ketogenic and Nutritional Interventions for Brain Energy Metabolism and Psychiatric Symptoms in First Episode Bipolar Disorder.
Overview
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.
Detailed description
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.
Interventions
- Other 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. - Other 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).
Primary outcome measures
- Change in brain redox nicotinamide adenine dinucleotide metabolites ratio (NAD+/NADH) [Time frame: 12 weeks]
- Change in brain creatine kinase forward reaction rate (kf) [Time frame: 12 weeks]
- Change in insulin resistance [Time frame: 12 weeks]
- Change in psychotic symptoms [Time frame: 12 weeks]
- Change in depressive symptoms [Time frame: 12 weeks]
- Change in mania symptoms [Time frame: 12 weeks]
- Change in Clinical Global Impression (CGI) Scale [Time frame: 12 weeks]
Secondary outcome measures (12)
- Change in body weight [Time frame: 12 weeks]
- Change in glycated hemoglobin (Hemoglobin A1c) level [Time frame: 12 weeks]
- Change in triglyceride levels [Time frame: 12 weeks]
- Change in low-density lipoprotein (LDL) levels [Time frame: 12 weeks]
- Change in high-density lipoprotein (HDL) levels [Time frame: 12 weeks]
- Change in high-sensitivity C-reactive protein (hs-CRP) levels [Time frame: 12 weeks]
- Change in brain gamma-aminobutyric acid (GABA) concentration [Time frame: 12 weeks]
- Change in brain glutamate metabolite concentration [Time frame: 12 weeks]
- Change in brain glutathione (GSH) [Time frame: 12 weeks]
- Change in brain Phosphocreatine (PCr) [Time frame: 12 weeks]
- Change in brain pH [Time frame: 12 weeks]
- Change in brain inorganic phosphate concentration [Time frame: 12 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- McLean Hospital — Belmont
Identifiers
NCT: NCT06221852 · 2023P002849