Dietary Intervention for Bipolar Disorder
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02272010|
Recruitment Status : Active, not recruiting
First Posted : October 22, 2014
Last Update Posted : August 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder||Other: Experimental Diet Other: Comparator Diet||Not Applicable|
The investigators will conduct a 2-arm, parallel group, randomized, controlled 24-week dietary intervention to evaluate the therapeutic efficacy of two dietary interventions in patients with BD. After a two-week baseline-monitoring period, the investigators will randomize 84 patients with chronic BD to augment usual treatment with either an experimentally-altered omega-3, omega-6 intervention or a control diet with average US intakes of n-3 and n-6 fatty acids. Subjects in both groups will remain under the care of their physician for the full duration of the trial. During the first phase of the trial (12 weeks), the intervention will be intense, during the second phase (12 weeks), a less intense intervention will be delivered, and after the two phases of intervention there will be a 24-week follow-up period.
The study is designed to achieve the following specific aims and obtain support for the following hypotheses:
Specific Aim 1 (primary mood outcome): To compare the efficacy of the experimental dietary intervention to the control diet in reducing variability of mood symptoms and reducing general psychological distress.
Hypothesis 1: Compared to the control diet, the experimental intervention will produce significant improvement in (1a) variability of daily mood symptoms, energy, and impulsivity using a Visual Analogue Scale measured using ecological momentary analysis (1); and (1b) psychological distress and general functioning using the PROMIS-29.
Specific Aim 2 (secondary mood outcome): To compare the efficacy of the experimental dietary intervention to the control diet in reducing recurrence.
Hypothesis 2: Compared to the control diet, the experimental intervention will produce significant reduction in recurrence of mood episodes over a 12-month period. To adequately power this study for measurement of recurrence, the investigators would need a sample size 2-3 times what the investigators estimate for this study, therefore the primary mood outcome is not recurrence of episode, but is measurement of mood variability, which in turn predicts recurrence. The investigators will measure recurrence to gather data for future studies.
Specific Aim 3 (primary biochemical outcome): To evaluate whether the experimental dietary intervention can alter n-6 AA and its bioactive metabolites, n-3 DHA and its bioactive metabolites in patients with BD.
Hypothesis 3: Compared to the control diet, the experimental intervention will significantly (1a) alter n-6 AA and n-3 DHA in erythrocytes; and (1b) alter 17-hydroxy DHA and reduce PGE2 in plasma.
Exploratory Aims: In an exploratory manner, the investigators will also (1) compare the efficacy of the experimental dietary intervention to the control diet in improving headache-related clinical endpoints in the subset of BP patients with comorbid migraines; (2) test the effects of the dietary interventions on a wide array of bioactive derivatives of n-3 and n-6 fatty acids and other inflammatory mediators (e.g. cytokines, CRP); and (3) evaluate whether biochemical alterations in n-3 DHA, n-6 AA and their bioactive metabolites are related to clinical improvements (4) compare the efficacy of the experimental dietary intervention to the control diet in preventing recurrence of illness in follow-up; (5) store samples for exploratory biomarker analysis.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||83 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Targeted Alterations in n-3 and n‐6 Fatty Acids for the Management of Mood Variability in the Maintenance Phase of Bipolar Disorder|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||February 2019|
Experimental: Experimental diet
Altered n-6 and n-3 fatty acid intake.
Other: Experimental Diet
Altered n-6 (linoleic acid) and n-3 (eicosapentaenic acid (EPA) + docosahexaenoic acid (DHA)) diet.
Active Comparator: Comparator Diet
Diet standardized to usual n-6 and n-3 intake.
Other: Comparator Diet
Diet standardized to the usual American distribution of n-6 (7%) and n-3 EPA+DHA (150 mg per day).
- Mood variability outcome [ Time Frame: Measured from the 2-week baseline period to the 12-week period of the phase 1 intervention ]Each individual will be given a smartphone for fourteen weeks (2 weeks baseline plus 12 week phase 1 intervention) to measure facets of mood, sleep, and pain.
- Recurrence of mood episode [ Time Frame: 1 year ]Recurrence will be measured through phone interviews and review of medical records.
- Plasma levels of omega-6 fatty acids [ Time Frame: Comparing from baseline to weeks 4, 8, 12 ]Group comparison of mean change from baseline in plasma levels of fatty acids, metabolites and lipidomics will be measured and analyzed in an exploratory fashion.
- Psychological distress and general functioning [ Time Frame: Baseline & weeks 0, 4, 8, 12 ]Measured by PROMIS-29
- Mood symptoms [ Time Frame: Baseline & weeks 0, 4, 8, 12, 24, 48 ]Mood, sleep, psychosocial stress and pain questionnaires.
- Plasma levels of omega-3 fatty acids [ Time Frame: Baseline & weeks 4, 8, 12 ]Group comparison of mean change from baseline in plasma levels of fatty acids, metabolites and lipidomics will be measured and analyzed in an exploratory fashion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272010
|United States, Pennsylvania|
|Milton S. Hershey Medical Center Clinical Research Center|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||Erika Saunders, M.D||Milton S. Hershey Medical Center|