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Examining Neurobiological Mechanisms Underlying the Therapeutic Effect of the Ketogenic Diet in Bipolar Disorder (BD) - Trial NCT06081426

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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NCT06081426
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Trial Details
ClinicalTrials.gov โ€ข NCT06081426
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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

Study Focus

Bipolar Disorder

Non-ketogenic Diet

Interventional

other

Sponsor & Location

University of Pittsburgh

Pittsburgh, United States of America

Timeline & Enrollment

N/A

Jan 01, 2024

Jan 01, 2027

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 disorder
Bipolar affective disorder, unspecified
Other bipolar affective disorders
Bipolar affective disorder, currently in remission
Bipolar affective disorder, current episode mixed

Data Source

ClinicalTrials.gov

NCT06081426

Non-Device Trial