Effects of Adding Chickpeas to the American Diet (Long Term Study)

NCT ID: NCT02375373

Last Updated: 2016-02-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-12-31

Brief Summary

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This prospective study will assess the effects of adding legumes, especially chick peas, to the diet of healthy adults on the commensal bacteria from feces of human subjects and resulting self-reported GI symptoms as well as markers of immune function.

Detailed Description

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Long-term observational study:

Subjects enrolled will participate in an observational setting for three months. During this time period, individuals will be encouraged, to maintain increased legume intake and explore new recipes that allow them to maintain a diverse menu of legume based foods. Fecal samples for microbiota analysis will be collected every month. Participants will record a weekly online questionnaire about legume intake and GI health as well as other health status updates. While participants will be encouraged to maintain regular intake of chickpeas throughout the long-term study, consumption of other legumes will be encouraged.

Conditions

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Inflammation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational Chickpea Diet

Observed long-term to study legume intake and GI health (Observational Chickpea Diet)

Observational Chickpea Diet

Intervention Type OTHER

Individuals encouraged to maintain increased legume intake and explore new recipes that allow them to maintain a diverse menu of legume based foods.

Fecal samples collected monthly.

Interventions

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Observational Chickpea Diet

Individuals encouraged to maintain increased legume intake and explore new recipes that allow them to maintain a diverse menu of legume based foods.

Fecal samples collected monthly.

Intervention Type OTHER

Other Intervention Names

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Go'Bonzo's

Eligibility Criteria

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Inclusion Criteria

* Good Health
* No systemic antibiotics during the preceding two months
* No medication suppressing immune function
* Willingness to provide basic demographic as well as medical history data

Exclusion Criteria

* Gastric Ulcers
* Inflammatory Bowel Disease (IBD) or Irritable Bowel Syndrome (IBS)
* Chronic constipation/diarrhea
* Body Mass Index (BMI) \> 30
* Dietary restrictions that prevent legume intake
* Currently on any medication that can affect GI transit time
* Consumption of \>3 servings/week of chickpeas or \>6 servings/week of legumes BEFORE study begins
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Pulse Association

OTHER

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Volker Mai, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

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Emerging Pathogens Institiute

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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201400716 Long Term

Identifier Type: -

Identifier Source: org_study_id

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