RecruitingNot ApplicableNCT06221852

Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder

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

Sponsor

Mclean Hospital

Enrollment

50 participants

Start Date

Mar 12, 2024

Study Type

INTERVENTIONAL

Conditions

Bipolar I Disorder Psychosis Schizoaffective Disorder

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 45 Years

Inclusion Criteria5

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 Criteria13

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

Interventions

OTHERKetogenic 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.

OTHERDietary 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).