Targeting the Microbiome to Improve Clinical Outcomes in Bipolar Disorder
Completed · Not applicable
Conditions studied: Bipolar Disorder
In brief
The objective of this study is to determine how specific dietary control alters the microbiome composition to effect clinical outcome measures in a longitudinal study of individuals with bipolar disorder. Our central hypothesis is that a low carbohydrate (CHO) / high polyunsaturated fat (PUFA) diet will increase the fractional representation of specific butyrate producing members of the Firmicutes phylum in the gut microbiome, which will attenuate host inflammation, improve sleep quality and reduce anxiety in bipolar patients. The rationale for the proposed research is to take the first step in a continuum of studies to develop personalized novel approaches to treat mood disorders, including the need to address gut dysbiosis, which often co-occurs with mental illness. The investigators will test our hypothesis and achieve the objective of this proposal with the following Specific Aims: 1) Determine the taxonomical change in the stool microbiome following a low CHO / high PUFA diet; and 2) Determine the changes in sleep quality, anxiety, and depression following a low CHO / high PUFA diet. These aims will be achieved using the unique resources at the University of Michigan, including the Nutrition Assessment Laboratory for dietary intervention, the Host-Microbiome Laboratory for microbial assays, and the ongoing Prechter Longitudinal Study of Bipolar Disorder. At the end of the proposed studies the investigators expect to set the stage for future studies to assess neurochemical mechanisms. These data will provide a greater understanding of the mechanism by which diet controls the specific microbes in the gut microbiome to affect mood disorders and gut dysbiosis and improve response to psychiatric treatment paradigms.
Key facts
- Study ID
- NCT02855762
- Run by
- Melvin McInnis, MD
- People needed
- 10
- Starts
- 2016-09-08
- Expected to finish
- 2019-01-31
- Last updated by the study team
- 2019-02-01
Who can join
Age: 25 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Current participation in Prechter Longitudinal Study of Bipolar disorder at the University of Michigan (HUM00000606)
- Confirmed diagnosis of Bipolar I or no diagnosis (controls)
You may not qualify if…
- Daily smoking habit
- Excessive alcohol defined as more than 2 drinks per day on average.
- An extremely poor diet determined by a nutritional interview as eating less than 1 planned meal per day.
- Food allergies or sensitivities.
- Anti-biotic use in the past 3 months.
Where it is running
- University of Michigan — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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