Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder

Part of paid clinical trials in Belmont, Massachusetts.

Sponsor
Mclean Hospital
Study ID
NCT06221852
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Ketogenic diet — OTHER
    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.
  • Dietary Guidelines for Americans — OTHER
    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).

Study Details

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.

Key Dates

Start date
Mar 12, 2024
Status verified
Nov 2025
Primary completion
Sep 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Ketogenic diet arm
    Eligible participants assigned to the ketogenic diet arm will be asked to follow the ketogenic diet (KD) for 12 weeks in addition to any ongoing medications (e.g., mood stabilizers and/or second-generation antipsychotics). Participants will receive weekly and as needed diet counseling from a registered dietician. Participants will be asked to monitor and report their blood ketone levels each day via a finger-prick device provided by the study team. Participants have the ability to opt into an optional open label phase where they can continue on the ketogenic diet with the daily finger pricks for another 12 weeks after the 12-week main study.
  • Active Comparator: Dietary Guidelines for Americans arm
    Eligible participants assigned to the Dietary Guidelines for Americans (DGA) arm will adhere to the Dietary Guidelines for Americans in addition to any ongoing medications (e.g., mood stabilizers and/or second-generation antipsychotics). Participants will receive weekly and as needed diet counseling from a registered dietician. Participants will be asked to monitor and report their blood ketone levels each day via a finger-prick device provided by the study team. Participants have the ability to opt into an optional open label phase where they can switch to the ketogenic diet with the daily finger pricks for 12 weeks after the 12-week main study.

Primary Outcome Measure

Change in brain redox nicotinamide adenine dinucleotide metabolites ratio (NAD+/NADH) [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
McLean HospitalBelmontMassachusetts02478
Jacey Anderson, B.A.
[email protected]
Virginie-Anne Chouinard, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Belmont, MA

By condition
Bipolar disorderSchizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
McLean Hospital· Belmont, MA

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