Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
50 participants
INTERVENTIONAL
2024-08-28
2027-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ketogenic diet
Participants 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 diet counseling from a registered dietitian. Participants will be asked to monitor and report their blood ketone and glucose levels each day via a finger-prick device provided by the study team.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
45 Years
ALL
No
Sponsors
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Baszucki Family Foundation
UNKNOWN
Mclean Hospital
OTHER
Responsible Party
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Virginie-Anne Chouinard, MD
Principal Investigator
Principal Investigators
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Virginie-Anne Chouinard, MD
Role: PRINCIPAL_INVESTIGATOR
Mclean Hospital
Locations
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McLean Hospital
Belmont, Massachusetts, United States
Countries
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Other Identifiers
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2023P002849-2
Identifier Type: -
Identifier Source: org_study_id
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