NCT02855762

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

September 8, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

2.4 years

First QC Date

June 10, 2016

Last Update Submit

January 30, 2019

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

  • Dietary effect on the fractional representation of faecalibacterium in the gut microbiome.

    The primary outcome will be measured as an increase in fractional representation of faecalibacterium, as measured by 16S ribosomal DNA sequencing of stool samples at baseline and 4 weeks of dietary manipulation. Sequence data will be analyzed as described in the mothur SOP (see links section of the PRS).

    Baseline and approximately 4 weeks from baseline

Study Arms (1)

Dietary Intervention Group

OTHER

Subject will be guided to eat a high polyunsaturated fatty acid diet.

Other: High polyunsaturated fatty acid diet.

Interventions

High polyunsaturated fatty acid diet.OTHER

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

Dietary Intervention Group

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Links

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Melvin McInnis, M.D.

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 10, 2016

First Posted

August 4, 2016

Study Start

September 8, 2016

Primary Completion

January 31, 2019

Study Completion

January 31, 2019

Last Updated

February 1, 2019

Record last verified: 2019-01

Locations

US(1)