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Awarded Trial: 13T-013
Grant ID
13T-013
Illness
bipolar
Primary Drug/Intervention
n-3 and n-6 fatty acids
Primary Dosage
N/A
Secondary Drug Intervention
N/A
Secondary Dosage
N/A
Other Drug/Intervention
N/A
Other Dosage
N/A
Status
Completed
Investigator
Saunders
Sample Size
84
Duration of Study Period for Each Subject
365 days
Outcome Measurements
N/A
Results
Eighty two patients with bipolar disorder with hypomanic or depressive symptoms were randomized to receive either a high n-3 plus low n-6 polyunsaturated fatty acid (PUFA) nutrition intervention or a control diet of usual U.S. levels of n-6 and n-3 fatty acid intakes over a 12 week period. The primary outcome was a change in day-to-day mood symptoms assessed with a Mood and Stress survey delivered randomly via smartphone two times per day, using an Ecological Momentary Assessment (EMA) paradigm. Blood was collected at weeks 4, 8 and 12 to determine if the nutritional intervention affected fatty acid levels in the plasma. The study was registered in ClinicalTrials.gov. Significant reductions in variability of mood, energy, irritability and pain were observed. Compared with control, patients in the intervention group had a 19% reduction in mood variability, 15% reduction in energy variability, 21% reduction in irritability variability, 35% reduction in variability of reported pain and 11% increase in thoughts of impulsivity. There was no difference in impulsive actions. The analyses of the n-6 arachidonic acid and n-3 docosahexaenoic acid in erythrocytes and 17-hydroxy docosahexaenoic acid and prostaglandin-E2 in plasma have not yet been reported to SMRI.
Publication
N/A
Link
N/A
PI Name
Erika Saunders
Degree
MD
Center
N/A
Institution
Pennsylvania State University College of Medicine
Address
500 University Drive
City or Town
Hershey
State or Province
PA
Zip or Postal Code
17033
Country
USA
Email Address
esaunders@hmc.psu.edu