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Targeting the Microbiome to Improve Clinical Outcomes in Bipolar Disorder

NCT02855762 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-02-01

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

High polyunsaturated fatty acid diet.

The investigators hypothesize the diet will improve gut health and psychiatric clinical outcomes.

Sponsors & Collaborators

  • Melvin McInnis, MD

    lead OTHER

Principal Investigators

  • Melvin McInnis, M.D. · University of Michigan

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-08
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02855762 on ClinicalTrials.gov