protocolSection identificationModule nctId: NCT06373016, orgStudyIdInfo id: 2015P000652, secondaryIdInfos id: 2023005, type: OTHER_GRANT, domain: Baszucki Foundation, briefTitle: Use of Ketosis in Modulating Metabolic Pathways in Bipolar Disorder, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-26, primaryCompletionDateStruct date: 2027-02-01, completionDateStruct date: 2027-02-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Stony Brook University, class: OTHER, collaborators name: Massachusetts General Hospital, collaborators name: Mclean Hospital, descriptionModule briefSummary: The goal of this clinical trial is to test how specific components of diet affect brain function and behavior for individuals with bipolar. The main question it aims to answer is how glucose and ketones each affect the brain's response to risk and reward. Participants will be asked to provide blood (to assess baseline measures of how the body uses energy), and then to receive two MRI scan sessions, on separate days. During each MRI scan session, participants will play three games, from which they can win money, before and after drinking glucose (on one day) or ketones (on the other day). Investigators will compare individuals with and without bipolar to test whether the two groups differ in how their brains use energy, and to test how the brain's use of energy affects behavior., conditionsModule conditions: Bipolar Disorder, conditions: Bipolar Disorder Type 1, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Glucose, interventions name: Ketones, outcomesModule primaryOutcomes measure: Stabilization of brain networks (general brain functioning), primaryOutcomes measure: Relative stabilization or destabilization of brain networks in response to metabolic bolus, primaryOutcomes measure: Prefrontal-limbic circuit regulation, primaryOutcomes measure: Cortico-striatal circuit regulation, primaryOutcomes measure: Concentration of neurometabolites measured by Magnetic Resonance Spectroscopy (MRS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: McLean Hospital, status: RECRUITING, city: Belmont, state: Massachusetts, zip: 02478, country: United States, contacts name: Dost Ongur, MD PhD, role: CONTACT, phone: 617-855-3922, email: dongur@mgb.org, contacts name: Virginie-Anne Chouinard, MD, role: CONTACT, phone: 617-855-3034, email: vchouinard@mgb.org, contacts name: Dost Ongur, MD PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.39593, lon: -71.17867, locations facility: Martinos Center for Biomedical Research, Building 149, 13th Street, status: RECRUITING, city: Charlestown, state: Massachusetts, zip: 02129, country: United States, contacts name: Lilianne Mujica-Parodi, PhD, role: CONTACT, phone: 631-428-8461, email: lstrey@mgh.harvard.edu, contacts name: Eva-Maria Ratai, PhD, role: CONTACT, phone: 781-521-4436, email: eratai@mgh.harvard.edu, contacts name: Eva-Maria Ratai, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.37787, lon: -71.062, locations facility: Laufer Center for Physical and Quantitative Biology, Stony Brook University, status: ACTIVE_NOT_RECRUITING, city: Stony Brook, state: New York, zip: 11794, country: United States, geoPoint lat: 40.92565, lon: -73.14094, hasResults: False