Use of Ketosis in Modulating Metabolic Pathways in Bipolar Disorder

Part of paid clinical trials in Belmont, Massachusetts.

Sponsor
Stony Brook University
Study ID
NCT06373016
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Glucose — DIETARY_SUPPLEMENT
    A glucose drink is administered midway through one of the scan sessions.
  • Ketones — DIETARY_SUPPLEMENT
    A ketone drink is administered midway through one of the scan sessions.

Study Details

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.

Key Dates

Start date
Jan 26, 2024
Status verified
Apr 2026
Primary completion
Feb 1, 2027
Completion
Feb 1, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Ketone Supplement-MRI/MRS
    Participants (both the Bipolar Cohort and Healthy Comparison Cohort) will be tested twice, both times in an overnight fasting condition (8 hours no food, unrestricted water). Halfway through each of the two scan sessions, participants will be asked to drink either glucose (on one day) or ketones (on the other day). This within-subjects comparison will allow investigators to observe the effects of metabolism on brain function. Participants' glucose and ketone levels will also be measured, using a finger-prick blood measurement at three different times: 1) immediately before the scan session 2) 10 minutes after drinking the glucose or supplement 3) immediately following the scan session.

Primary Outcome Measure

Stabilization of brain networks (general brain functioning) [ Time Frame: Within a month of enrollment completion ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
McLean HospitalBelmontMassachusetts02478
Dost Ongur, MD PhD
[email protected]
617-855-3922
Virginie-Anne Chouinard, MD
[email protected]
617-855-3034
Dost Ongur, MD PhD (PRINCIPAL_INVESTIGATOR)
Martinos Center for Biomedical Research, Building 149, 13th StreetCharlestownMassachusetts02129
Lilianne Mujica-Parodi, PhD
[email protected]
631-428-8461
Eva-Maria Ratai, PhD
[email protected]
781-521-4436
Eva-Maria Ratai, PhD (PRINCIPAL_INVESTIGATOR)
Laufer Center for Physical and Quantitative Biology , Stony Brook UniversityStony BrookNew York11794-

Find similar trials in Belmont, MA

By condition
Bipolar disorder
By specialty
PsychiatryMental healthBehavioral health
By research site
McLean Hospital· Belmont, MAMartinos Center for Biomedical Research, Building 149, 13th Street· Charlestown, MALaufer Center for Physical and Quantitative Biology , Stony Brook University· Stony Brook, NY

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