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NCT06081426Not yet recruiting

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

Elucidating Neurobiological Mechanisms Underlying the Therapeutic Effect of the Ketogenic Diet in Bipolar Disorder (BD): a Multidisciplinary Mechanistic Study
University of PittsburghClinicalTrials.govother
Study focus
Disease/Condition
Bipolar Disorder
Drug/Device/Intervention
Non-ketogenic Diet
Study type
Interventional
Intervention type
other
Sponsor & location
Primary sponsor
University of Pittsburgh
Location
Pittsburgh, United States of America
Timeline & enrollment
Phase
N/A
Start date
Jan 01, 2024
End date
Jan 01, 2027
Enrollment
107 participants
Primary outcome

Blood oxygen level-dependent (BOLD) signal at Scan 1,Blood oxygen level-dependent (BOLD) signal at Scan 2,Blood oxygen level-dependent (BOLD) signal at Scan 3,Manic symptoms at Scan 1,Manic symptoms at Scan 2,Manic symptoms at Scan 3,Fasting Glucose at Baseline,Fasting lipids at Baseline,Fasting hepatic function panel at Baseline: total protein,Fasting hepatic function panel at Baseline: albumin,Fasting hepatic function panel at Baseline: bilirubin,Fasting hepatic function panel at Baseline: liver enzyme,Fasting Glucose at halfway point through first dietary phase,Fasting lipids at halfway point through first dietary phase,Fasting hepatic function at halfway point through first dietary phase: total protein,Fasting hepatic function at halfway point through first dietary phase: albumin,Fasting hepatic function at halfway point through first dietary phase: bilirubin,Fasting hepatic function at halfway point through first dietary phase: liver enzyme,Fasting Glucose at end of first dietary phase,Fasting lipids at end of first dietary phase,Fasting hepatic function at end of first dietary phase: total protein,Fasting hepatic function at end of first dietary phase: albumin,Fasting hepatic function at end of first dietary phase: bilirubin,Fasting hepatic function at end of first dietary phase: liver enzyme,Fasting Glucose at halfway point through second dietary phase,Fasting lipids at halfway point through second dietary phase,Fasting hepatic function at halfway point through second dietary phase: total protein,Fasting hepatic function at halfway point through second dietary phase: albumin,Fasting hepatic function at halfway point through second dietary phase: bilirubin,Fasting hepatic function at halfway point through second dietary phase: liver enzyme,Fasting Glucose at end of second dietary phase,Fasting lipids at end of second dietary phase,Fasting hepatic function at end of second dietary phase: total protein,Fasting hepatic function at end of second dietary phase: albumin,Fasting hepatic function at end of second dietary phase: bilirubin,Fasting hepatic function at end of second dietary phase: liver enzyme,Gamma-aminobutyric acid (GABA) at Baseline,Glutamate at Baseline,Lactate at Baseline,Gamma-aminobutyric acid (GABA) at end of first dietary phase,Glutamate at end of first dietary phase,Lactate at end of first dietary phase,Gamma-aminobutyric acid (GABA) at end of second dietary phase,Glutamate at end of second dietary phase,Lactate at end of second dietary phase

Summary

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

ICD-10 classifications
Bipolar affective disorderBipolar affective disorder, unspecifiedOther bipolar affective disordersBipolar affective disorder, currently in remissionBipolar affective disorder, current episode mixed
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06081426
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06081426 through Pure Global AI's free database. This phase not specified trial is sponsored by University of Pittsburgh and is currently Not yet recruiting. The study focuses on Bipolar Disorder. Target enrollment is 107 participants.

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