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

January 22, 2016 updated by: University of Florida

Effects of Adding Chickpeas to the American Diet on Fecal Microbiota Composition and Markers of Inflammation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32608
        • Emerging Pathogens Institiute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals directly associated with the University of Florida (faculty, staff, students) or through the University of Florida's Health Street program.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational Chickpea Diet
Observed long-term to study legume intake and GI health (Observational Chickpea Diet)
Other: 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.

Other Names:
  • Go'Bonzo's

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Number of 16S RNA Sequences on Days 31, Day 62, and Day 93.
Time Frame: Change from Day 31, Day 62, and Day 93
Compare the gut microbiota composition of individual subjects before and after the implementation of a controlled and observed diet of chickpeas and legume products.
Change from Day 31, Day 62, and Day 93

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

American Pulse Association

Investigators

  • Principal Investigator: Volker Mai, PhD, MPH, Associate professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

February 24, 2015

First Submitted That Met QC Criteria

February 24, 2015

First Posted (Estimate)

March 2, 2015

Study Record Updates

Last Update Posted (Estimate)

February 19, 2016

Last Update Submitted That Met QC Criteria

January 22, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201400716 Long Term

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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