Examining Neurobiological Mechanisms Underlying the Therapeutic Effect of the Ketogenic Diet in Bipolar Disorder (BD) (NCT06081426)
Elucidating Neurobiological Mechanisms Underlying the Therapeutic Effect of the Ketogenic Diet in Bipolar Disorder (BD): a Multidisciplinary Mechanistic Study
🩺 Plain-English Summary (8th-Grade Level)
The investigators aim to examine the effect of the ketogenic diet on brain activity, metabolism, and emotions in adults with Bipolar Disorder (BD).
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (13 items) and avoid the listed exclusions (28 items).
Location: University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania
Age range: 18 Years to 40 Years
🧪 Interventions in This Study
- Non-ketogenic Diet (OTHER)
- Ketogenic Diet (OTHER)
- No diet (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria: All participants:
- Not between 18-40 years of age
- History of head injury, neurological, pervasive developmental disorder (e.g. autism), systemic medical disease and treatment (medical records, participant report)
- Mini-Mental State Examination score (cognitive state) \<24
- Premorbid National Adult Reading Test Intelligent Quotient (NAART IQ) estimate\<85
- Visual disturbance: \<20/40 Snellen visual acuity
- History of alcohol/substance use disorder (SUD; all substances, including nicotine), and/or illicit substance use (except cannabis) over the last 6 months (SCID-5). Note: lifetime/present cannabis use (at non-abuse (\<3 times in the past month) and non SUD levels) will be allowed, given its common usage in BD and young adults. Cannabis SUD over the last 6 months will not be allowed. Urine tests on scan days will exclude current illicit substance use (except cannabis). Salivary alcohol tests on scan days will exclude intoxicated individuals
- MRI exclusion: metallic objects, e.g., surgical implants; claustrophobia; positive pregnancy test for females or self-report pregnancy
- Unable to understand English
- Conditions related to the pancreas, liver, thyroid or gallbladder.
- Taking anticoagulants and/or those with blood dyscrasias (illnesses) who have coagulation disorders (eg, hemophilia) because of the ketomojo finger stick blood tests
- Scoring 3 or higher on positive symptom factor questions on the Positive and Negative Syndrome Scale (PANSS) questionnaire (indicative of psychotic symptoms)
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania
📞 Contact the Study Coordinator
Phone: (412) 383-8206
Email: morristillmanje@upmc.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Bipolar Disorder
- Three-level Model of DBT-informed Care for Youth With and/or at Familial Risk for Bipolar Disorder (DB3) — Toronto, Ontario
- Pragmatic Patient-oriented Extension Study of Dialectical Behavior Therapy Booster Sessions for Youth With and/or at Familial Risk for Bipolar Disorder — Toronto, Ontario
- Early Intervention for Youth at High Risk for Bipolar Disorder — Pittsburgh, Pennsylvania
- Magnetic Seizure Therapy in Bipolar Depression (MST-BpD) and Treatment Resistant Depression (MST-TRD) — Houston, Texas
- Intermittent Theta Burst Stimulation (iTBS) for Emotion Regulation in Bipolar Disorder — Charlestown, Massachusetts
Explore by condition: All Bipolar Disorder clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.