NCT06081426
Examining Neurobiological Mechanisms Underlying the Therapeutic Effect of the Ketogenic Diet in Bipolar Disorder (BD)
At risk: Primary completion moved at least 4 months later.
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Record History
All 5 versions: 5 with changes below. See every version on ClinicalTrials.gov ↗
- Notable Eligibility criteria expanded, about 106 words
- Primary and study completion pushed from Jan 2027 to Jun 2027
- Secondary endpoints: details revised at 4 of 8 entries
- Minor Site contact updatedv4
- Notable Eligibility criteria expanded, about 58 words
- Site contact updated
- Notable Trial status: Not Yet Recruiting to Recruiting
- Start date changed from estimate of Jan 2024 to Jan 12, 2024
- Site details revised
- Study First Submitted
- Notable: the plan changed
- Minor: routine updates
Endpoints
Primary
Blood oxygen level-dependent (BOLD) signal at Scan 1
Timeframe: Baseline Scan 1 (all participants)
Blood oxygen level-dependent (BOLD) signal at Scan 2
Timeframe: End of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Blood oxygen level-dependent (BOLD) signal at Scan 3
Timeframe: End of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Manic symptoms at Scan 1
Timeframe: Baseline Scan 1 (all participants)
Manic symptoms at Scan 2
Timeframe: Scan 2 at end of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Manic symptoms at Scan 3
Timeframe: Scan 3 at end of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting Glucose at Baseline
Timeframe: Baseline (all participants)
Fasting lipids at Baseline
Timeframe: Baseline (all participants)
Fasting hepatic function panel at Baseline: total protein
Timeframe: Baseline (all participants)
Fasting hepatic function panel at Baseline: albumin
Timeframe: Baseline (all participants)
Fasting hepatic function panel at Baseline: bilirubin
Timeframe: Baseline (all participants)
Fasting hepatic function panel at Baseline: liver enzyme
Timeframe: Baseline (all participants)
Fasting Glucose at halfway point through first dietary phase
Timeframe: Halfway point through first dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting lipids at halfway point through first dietary phase
Timeframe: Halfway point through first dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting hepatic function at halfway point through first dietary phase: total protein
Timeframe: Halfway point through first dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting hepatic function at halfway point through first dietary phase: albumin
Timeframe: Halfway point through first dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting hepatic function at halfway point through first dietary phase: bilirubin
Timeframe: Halfway point through first dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting hepatic function at halfway point through first dietary phase: liver enzyme
Timeframe: Halfway point through first dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting Glucose at end of first dietary phase
Timeframe: End of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting lipids at end of first dietary phase
Timeframe: End of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting hepatic function at end of first dietary phase: total protein
Timeframe: End of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting hepatic function at end of first dietary phase: albumin
Timeframe: End of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting hepatic function at end of first dietary phase: bilirubin
Timeframe: End of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting hepatic function at end of first dietary phase: liver enzyme
Timeframe: End of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting Glucose at halfway point through second dietary phase
Timeframe: Halfway point through second dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting lipids at halfway point through second dietary phase
Timeframe: Halfway point through second dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting hepatic function at halfway point through second dietary phase: total protein
Timeframe: Halfway point through second dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting hepatic function at halfway point through second dietary phase: albumin
Timeframe: Halfway point through second dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting hepatic function at halfway point through second dietary phase: bilirubin
Timeframe: Halfway point through second dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting hepatic function at halfway point through second dietary phase: liver enzyme
Timeframe: Halfway point through second dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Fasting Glucose at end of second dietary phase
Timeframe: End of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting lipids at end of second dietary phase
Timeframe: End of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting hepatic function at end of second dietary phase: total protein
Timeframe: End of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting hepatic function at end of second dietary phase: albumin
Timeframe: End of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting hepatic function at end of second dietary phase: bilirubin
Timeframe: End of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Fasting hepatic function at end of second dietary phase: liver enzyme
Timeframe: End of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Gamma-aminobutyric acid (GABA) at Baseline
Timeframe: Baseline Scan 1 (all participants)
Glutamate at Baseline
Timeframe: Baseline Scan 1 (all participants)
Lactate at Baseline
Timeframe: Baseline Scan 1 (all participants)
Gamma-aminobutyric acid (GABA) at end of first dietary phase
Timeframe: Scan 2 at end of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Glutamate at end of first dietary phase
Timeframe: Scan 2 at end of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Lactate at end of first dietary phase
Timeframe: Scan 2 at end of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Gamma-aminobutyric acid (GABA) at end of second dietary phase
Timeframe: Scan 3 at end of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Glutamate at end of second dietary phase
Timeframe: Scan 3 at end of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Lactate at end of second dietary phase
Timeframe: Scan 3 at end of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Secondary (8)
Average total sleep time during Ketogenic vs Normal diet
Average rest-activity rhythm interdaily stability during Ketogenic vs Normal diet
Ecological momentary assessments (EMA) during the first dietary phase: Mood monitoring
Ecological momentary assessments (EMA) during the first dietary phase: Energy monitoring
Ecological momentary assessments (EMA) during the first dietary phase: Suicidality monitoring
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Ecological momentary assessments (EMA) during the second dietary phase: Mood monitoring
Ecological momentary assessments (EMA) during the second dietary phase: Energy monitoring
Ecological momentary assessments (EMA) during the second dietary phase: Suicidality monitoring
Arms and interventions
1st phase Non-ketogenic Diet / 2nd phase Ketogenic DietExperimental
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
1st phase Ketogenic Diet / 2nd phase Non-ketogenic DietExperimental
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
No dietOther
Participants without Bipolar Disorder will not participate in the diet phases of the study
Other: Non-ketogenic Diet, Ketogenic Diet, No diet
Sites
1 site in 1 country
- University of Pittsburgh Medical CenterPittsburgh, Pennsylvania, United States