Examining Neurobiological Mechanisms Underlying the Therapeutic Effect of the Ketogenic Diet in Bipolar Disorder (BD)

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT06081426
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • Non-ketogenic Diet — OTHER
    Consuming a non-ketogenic diet
  • Ketogenic Diet — OTHER
    Consuming a ketogenic diet
  • No diet — OTHER
    Participants without Bipolar Disorder will not participate in the diet phases of the study

Study Details

The investigators aim to examine the effect of the ketogenic diet on brain activity, metabolism, and emotions in adults with Bipolar Disorder (BD).

Key Dates

Start date
Jan 12, 2024
Status verified
Dec 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
107 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 1st phase Non-ketogenic Diet / 2nd phase Ketogenic Diet
    Participants with Bipolar Disorder will consume a non-ketogenic diet for the first phase of the study and then a ketogenic diet for the second phase of the study
  • Experimental: 1st phase Ketogenic Diet / 2nd phase Non-ketogenic Diet
    Participants with Bipolar Disorder will consume a ketogenic diet for the first phase of the study and then a non-ketogenic diet for the second phase of the study
  • Other: No diet
    Participants without Bipolar Disorder will not participate in the diet phases of the study

Primary Outcome Measure

Blood oxygen level-dependent (BOLD) signal at Scan 1 [ Time Frame: Baseline Scan 1 (all participants) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pittsburgh Medical CenterPittsburghPennsylvania15213
Jill Morris-Tillman
[email protected]
412-383-8206
Mary L Phillps, MD, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Pittsburgh, PA

By condition
Bipolar disorder
By specialty
PsychiatryMental healthBehavioral health
By research site
University of Pittsburgh Medical Center· Pittsburgh, PA

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