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| Name | Class |
|---|---|
| Baszucki Brain Research Fund | OTHER |
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The investigators aim to examine the effect of the ketogenic diet on brain activity, metabolism, and emotions in adults with Bipolar Disorder (BD).
The investigators hypothesize that a ketogenic diet will enhance levels of the ketone body β-Hydroxybutyrate (beta OHB), resulting in reduced mania/hypomania severity and predisposition to mania/hypomania in individuals with BD. To test this hypothesis in depth, the investigators will use a novel, multidisciplinary mechanistic study using multimodal neuroimaging, peripheral markers of mitochondrial metabolism, and participant-derived induced pluripotent stem cell (iPSC)-derived organoids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1st phase Non-ketogenic Diet / 2nd phase Ketogenic Diet | Experimental | 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 Diet | Experimental | 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 diet | Other | Participants without Bipolar Disorder will not participate in the diet phases of the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-ketogenic Diet | Other | Consuming a non-ketogenic diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood oxygen level-dependent (BOLD) signal at Scan 1 | The blood oxygen level-dependent (BOLD) signal indicates brain activity and connectivity | Baseline Scan 1 (all participants) |
| Blood oxygen level-dependent (BOLD) signal at Scan 2 | The blood oxygen level-dependent (BOLD) signal indicates brain activity and connectivity | End of first dietary phase (8-10 weeks) (participants with Bipolar Disorder) |
| Blood oxygen level-dependent (BOLD) signal at Scan 3 | The blood oxygen level-dependent (BOLD) signal indicates brain activity and connectivity | End of second dietary phase (8-10 weeks) (participants with Bipolar Disorder) |
| Manic symptoms at Scan 1 | The Young Mania Rating Scale (YMRS) indicates the level of manic symptoms with a total score that varies between zero (better outcome) and 60 (worse outcome) | Baseline Scan 1 (all participants) |
| Manic symptoms at Scan 2 | The Young Mania Rating Scale (YMRS) indicates the level of manic symptoms with a total score that varies between zero (better outcome) and 60 (worse outcome) | Scan 2 at end of first dietary phase (8-10 weeks) (participants with Bipolar Disorder) |
| Manic symptoms at Scan 3 | The Young Mania Rating Scale (YMRS) indicates the level of manic symptoms with a total score that varies between zero (better outcome) and 60 (worse outcome) | Scan 3 at end of second dietary phase (8-10 weeks) (participants with Bipolar Disorder) |
| Measure | Description | Time Frame |
|---|---|---|
| Average total sleep time during Ketogenic vs Normal diet | Total sleep time will be assessed using wrist actigraphy. Wrist actigraphy will be collected continuously, at-home. | Wrist actigraphy will be collected throughout the 8-10wk ketogenic diet and normal diet study intervals |
| Average rest-activity rhythm interdaily stability during Ketogenic vs Normal diet |
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Inclusion Criteria:
All participants:
BD hypomanic group (n=30):
BD euthymic group (n=30):
Healthy Control (HC) Group (n=30):
Exclusion Criteria:
All participants:
BD hypomanic group:
BD euthymic group:
Healthy Control (HC) Group
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jill Morris-Tillman | Contact | 412-383-8206 | morristillmanje@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mary Phillips, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
Informed consent will be collected from study participants that allows for broad sharing of participants' de-identified data. Data transfer procedures will be in accordance with all Institutional Review Board guidelines and federal regulations including HIPAA (Health Insurance Portability and Accountability Act of 1996).
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The principal investigators (PIs) reserve the right to publish on the stated aims in a timely manner. Data will be available for addressing other research questions (i.e. which are not described in funded/pending grants) as soon as the data have been checked for accuracy (a period which will be no later than one year after the completion of each assessment). After the study has ended, the study investigators will continue to test the stated aims, but will also continue to solicit collaborations with outside researchers and to consider data requests in a timely manner.
Outside investigators must submit a 1)proposal of the study aims, hypotheses, variables/constructs, analytic approach, and estimated duration of the proposed research; 2)resume, qualifications, source of financial support, and conflict of interest statement; 3)sign a data-sharing agreement and confidentiality statement that stipulates using the data for the stated research purposes only, securing the data using appropriate computer technology, not manipulating the data in order to identify participants, acknowledging the grant that supported data collection and management in publications/presentations, and destroying or returning the data after analyses are complete; 4)obtain approval from their Institutional Review Board, and along with other staff members who have access to the data, submit certificates of the University of Pittsburgh Education and Certification Program in Research Practice Fundamentals or provide written documentation of similar human subjects protection training.
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D055423 | Diet, Ketogenic |
| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| Ketogenic Diet | Other | Consuming a ketogenic diet |
|
| No diet | Other | Participants without Bipolar Disorder will not participate in the diet phases of the study |
|
| Fasting Glucose at Baseline | Fasting glucose blood levels | Baseline (all participants) |
| Fasting lipids at Baseline | Fasting lipid blood levels | Baseline (all participants) |
| Fasting hepatic function panel at Baseline: total protein | Fasting levels of total protein in the blood | Baseline (all participants) |
| Fasting hepatic function panel at Baseline: albumin | Fasting levels of albumin in the blood | Baseline (all participants) |
| Fasting hepatic function panel at Baseline: bilirubin | Fasting levels of bilirubin in the blood | Baseline (all participants) |
| Fasting hepatic function panel at Baseline: liver enzyme | Fasting levels of liver enzyme in the blood | Baseline (all participants) |
| Fasting Glucose at halfway point through first dietary phase | Fasting glucose blood levels | Halfway point through first dietary phase (4-5 weeks) (participants with Bipolar Disorder) |
| Fasting lipids at halfway point through first dietary phase | Fasting lipid blood levels | 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 | Fasting levels of total protein in the blood | Halfway point through first dietary phase (4-5 weeks) (participants with Bipolar Disorder) |
| Fasting hepatic function at halfway point through first dietary phase: albumin | Fasting levels of albumin in the blood | Halfway point through first dietary phase (4-5 weeks) (participants with Bipolar Disorder) |
| Fasting hepatic function at halfway point through first dietary phase: bilirubin | Fasting levels of bilirubin in the blood | 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 | Fasting levels of liver enzyme in the blood | Halfway point through first dietary phase (4-5 weeks) (participants with Bipolar Disorder) |
| Fasting Glucose at end of first dietary phase | Fasting glucose blood levels | End of first dietary phase (8-10 weeks) (participants with Bipolar Disorder) |
| Fasting lipids at end of first dietary phase | Fasting lipid blood levels | End of first dietary phase (8-10 weeks) (participants with Bipolar Disorder) |
| Fasting hepatic function at end of first dietary phase: total protein | Fasting levels of total protein in the blood | End of first dietary phase (8-10 weeks) (participants with Bipolar Disorder) |
| Fasting hepatic function at end of first dietary phase: albumin | Fasting levels of albumin in the blood | End of first dietary phase (8-10 weeks) (participants with Bipolar Disorder) |
| Fasting hepatic function at end of first dietary phase: bilirubin | Fasting levels of bilirubin in the blood | End of first dietary phase (8-10 weeks) (participants with Bipolar Disorder) |
| Fasting hepatic function at end of first dietary phase: liver enzyme | Fasting levels of liver enzyme in the blood | End of first dietary phase (8-10 weeks) (participants with Bipolar Disorder) |
| Fasting Glucose at halfway point through second dietary phase | Fasting glucose blood levels | Halfway point through second dietary phase (4-5 weeks) (participants with Bipolar Disorder) |
| Fasting lipids at halfway point through second dietary phase | Fasting lipid blood levels | 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 | Fasting levels of total protein in the blood | Halfway point through second dietary phase (4-5 weeks) (participants with Bipolar Disorder) |
| Fasting hepatic function at halfway point through second dietary phase: albumin | Fasting levels of albumin in the blood | Halfway point through second dietary phase (4-5 weeks) (participants with Bipolar Disorder) |
| Fasting hepatic function at halfway point through second dietary phase: bilirubin | Fasting levels of bilirubin in the blood | 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 | Fasting levels of liver enzyme in the blood | Halfway point through second dietary phase (4-5 weeks) (participants with Bipolar Disorder) |
| Fasting Glucose at end of second dietary phase | Fasting glucose blood levels | End of second dietary phase (8-10 weeks) (participants with Bipolar Disorder) |
| Fasting lipids at end of second dietary phase | Fasting lipids blood levels | End of second dietary phase (8-10 weeks) (participants with Bipolar Disorder) |
| Fasting hepatic function at end of second dietary phase: total protein | Fasting levels of total protein in the blood | End of second dietary phase (8-10 weeks) (participants with Bipolar Disorder) |
| Fasting hepatic function at end of second dietary phase: albumin | Fasting levels of albumin in the blood | End of second dietary phase (8-10 weeks) (participants with Bipolar Disorder) |
| Fasting hepatic function at end of second dietary phase: bilirubin | Fasting levels of bilirubin in the blood | End of second dietary phase (8-10 weeks) (participants with Bipolar Disorder) |
| Fasting hepatic function at end of second dietary phase: liver enzyme | Fasting levels of liver enzyme in the blood | End of second dietary phase (8-10 weeks) (participants with Bipolar Disorder) |
| Gamma-aminobutyric acid (GABA) at Baseline | Gamma-aminobutyric acid (GABA) concentrations in the brain | Baseline Scan 1 (all participants) |
| Glutamate at Baseline | Glutamate concentrations in the brain | Baseline Scan 1 (all participants) |
| Lactate at Baseline | Lactate concentrations in the brain | Baseline Scan 1 (all participants) |
| Gamma-aminobutyric acid (GABA) at end of first dietary phase | Gamma-aminobutyric acid (GABA) concentrations in the brain | Scan 2 at end of first dietary phase (8-10 weeks) (participants with Bipolar Disorder) |
| Glutamate at end of first dietary phase | Glutamate concentrations in the brain | Scan 2 at end of first dietary phase (8-10 weeks) (participants with Bipolar Disorder) |
| Lactate at end of first dietary phase | Lactate concentrations in the brain | 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 | Gamma-aminobutyric acid (GABA) concentrations in the brain | Scan 3 at end of second dietary phase (8-10 weeks) (participants with Bipolar Disorder) |
| Glutamate at end of second dietary phase | Glutamate concentrations in the brain | Scan 3 at end of second dietary phase (8-10 weeks) (participants with Bipolar Disorder) |
| Lactate at end of second dietary phase | Lactate concentrations in the brain | Scan 3 at end of second dietary phase (8-10 weeks) (participants with Bipolar Disorder) |
Rest-activity rhythm interdaily stability will be assessed using wrist actigraphy. Wrist actigraphy will be collected continuously, at-home |
| Wrist actigraphy will be collected throughout the 8-10 wk ketogenic diet and normal diet study intervals. |
| Ecological momentary assessments (EMA) during the first dietary phase: Mood monitoring | Mood monitoring in real time in participants with Bipolar Disorder: rate mood on a scale of 1-7 with 1 being very low mood and 7 being very high mood | The first dietary phase (8-10 weeks) (participants with Bipolar Disorder) |
| Ecological momentary assessments (EMA) during the first dietary phase: Energy monitoring | Energy monitoring in real time in participants with Bipolar Disorder: rate energy on a scale of 1-7 with 1 being very low energy and 7 being very high energy | The first dietary phase (8-10 weeks) (participants with Bipolar Disorder) |
| Ecological momentary assessments (EMA) during the first dietary phase: Suicidality monitoring | Suicidality monitoring in real time in participants with Bipolar Disorder: answer yes or no to having self-harm/suicide thoughts and plans | The first dietary phase (8-10 weeks) (participants with Bipolar Disorder) |
| Ecological momentary assessments (EMA) during the second dietary phase: Mood monitoring | Mood monitoring in real time in participants with Bipolar Disorder: rate mood on a scale of 1-7 with 1 being very low mood and 7 being very high mood | The second dietary phase (8-10 weeks) (participants with Bipolar Disorder) |
| Ecological momentary assessments (EMA) during the second dietary phase: Energy monitoring | Energy monitoring in real time in participants with Bipolar Disorder: rate energy on a scale of 1-7 with 1 being very low energy and 7 being very high energy | The second dietary phase (8-10 weeks) (participants with Bipolar Disorder) |
| Ecological momentary assessments (EMA) during the second dietary phase: Suicidality monitoring | Suicidality monitoring in real time in participants with Bipolar Disorder: answer yes or no to having self-harm/suicide thoughts and plans | The second dietary phase (8-10 weeks) (participants with Bipolar Disorder) |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |