Recruiting

Ketosis

Sponsor:

Stony Brook University

Code:

NCT06373016

Conditions

Bipolar Disorder

Bipolar Disorder Type 1

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Glucose

Ketones

Study Details

Brief summary:

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.

Conditions

Bipolar Disorder

Bipolar Disorder Type 1

Study ID

NCT06373016

Start date

Jan 26, 2024

Status verified date

Apr, 2026

Completion date

Feb 1, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion/Exclusion Criteria:

  • Bipolar disorder diagnosis: Patients must have a Diagnostic Statistical Manual (DSM)-V diagnosis of bipolar disorder on the Structured Clinical Interview for DSM (SCID)
  • Bipolar disorder symptoms: Patients must be stable and euthymic at time of consent and testing, documented by no hospitalizations in the prior 4 weeks
  • Age: between 18-45 yrs for patients with bipolar disorder and age-matched controls
  • Weight does not exceed 350lbs.
  • Diameter does not exceed 60 cm when supine
  • HbA1C < 7%
  • No non-MRI-compatible metal in the body (e.g., pacemaker, shrapnel, joint pins)
  • No claustrophobia
  • No history of significant head injury
  • No history of electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within the last 3 months
  • No history of previous treatment with following procedures: vagus nerve stimulation, or deep brain stimulation
  • Are not deemed a serious suicide or homicide risk
  • No unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease
  • No seizure disorders
  • Have the capacity to sign informed consent
  • No current diagnosis or history of an alcohol or substance use disorder in the last 6 months or positive test for an illicit drug on the screening urine analysis (positive cannabis screen is not exclusionary): confirmed using urine toxicology test during the initial screening visit and before each MRI scan visit.
  • For Healthy Volunteers Only: No psychotropic medication and no history of neurological disease
  • Must have vision that is 20/20 or correctable to 20/20 with contact lenses
  • No Type 1 diabetes mellitus
  • No regular consumption of insulin and other antidiabetics, like Metformin®, GLP1-RA's and others.
  • No kidney disease, as determined by medical history and/or blood work
  • No history of heart attack or stroke
  • No difficulty swallowing
  • No myxedema
  • No Pregnancy (pre-menopausal females): confirmed during medical screening and each MRI scan visit using a urine test
  • No breastfeeding

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Glucose

A glucose drink is administered midway through one of the scan sessions.

Ketones

A ketone drink is administered midway through one of the scan sessions.

Primary outcome measure

  • Stabilization of brain networks (general brain functioning) [ Time Frame: Within a month of enrollment completion ]
  • Relative stabilization or destabilization of brain networks in response to metabolic bolus [ Time Frame: Within a month of enrollment completion ]
  • Prefrontal-limbic circuit regulation [ Time Frame: Within a month of enrollment completion ]
  • Cortico-striatal circuit regulation [ Time Frame: Within a month of enrollment completion ]
  • Concentration of neurometabolites measured by Magnetic Resonance Spectroscopy (MRS) [ Time Frame: Within a month of enrollment completion ]

Central Contacts and Locations

Central contacts

Stephen Burke, BS

914-325-0868stephen.j.burke@stonybrook.edu

Sadia Jumana, BS

339-241-2515sadiaanjum.jumana@stonybrook.edu

Locations

McLean Hospital

Recruiting

Belmont, Massachusetts, United States, 02478

Contacts

Dost Ongur, MD PhD

617-855-3922dongur@mgb.org

Virginie-Anne Chouinard, MD

617-855-3034vchouinard@mgb.org

Principal Investigator:

Dost Ongur, MD PhD

Martinos Center for Biomedical Research, Building 149, 13th Street

Recruiting

Charlestown, Massachusetts, United States, 02129

Contacts

Lilianne Mujica-Parodi, PhD

631-428-8461lstrey@mgh.harvard.edu

Eva-Maria Ratai, PhD

781-521-4436eratai@mgh.harvard.edu

Principal Investigator:

Eva-Maria Ratai, PhD

More Information

Sponsor

Stony Brook University

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stony Brook University on 2026-04-15.