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

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

Plain Language Summary

Simplified for easier understanding

This study is testing whether dietary changes — specifically a ketogenic (very low carbohydrate, high fat) diet and other nutritional approaches — can improve symptoms and brain health in people who have recently been diagnosed with bipolar disorder or schizoaffective disorder. **You may be eligible if...** - You are between 18 and 45 years old - You have been diagnosed with bipolar I disorder or schizoaffective disorder in the last 7 years - Your psychiatric condition is currently stable and your medications have not changed in the past 2 weeks - You are able and willing to follow the study diet for 12 weeks **You may NOT be eligible if...** - You are pregnant, nursing, or not using contraception - You have type 1 or type 2 diabetes - You currently have a substance use disorder - Your BMI is under 20 or you weigh over 350 pounds - You have an unstable medical condition (heart, liver, kidney, lung, or neurological disease) - You have had gastric bypass or weight loss surgery - You have a condition called familial hypercholesterolemia (very high inherited cholesterol) - You currently have cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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).


Locations(1)

McLean Hospital

Belmont, Massachusetts, United States

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NCT06221852


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