Effects of Adding Chickpeas to the American Diet (Long Term Study)
1 other identifier
observational
12
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2015
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2015
CompletedFirst Posted
Study publicly available on registry
March 2, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedResults Posted
Study results publicly available
February 19, 2016
CompletedFebruary 19, 2016
January 1, 2016
8 months
February 24, 2015
December 1, 2015
January 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in Number of 16S RNA Sequences on Days 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
Study Arms (1)
Observational Chickpea Diet
Observed long-term to study legume intake and GI health (Observational Chickpea Diet)
Interventions
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.
Eligibility Criteria
Individuals directly associated with the University of Florida (faculty, staff, students) or through the University of Florida's Health Street program.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- American Pulse Associationcollaborator
Study Sites (1)
Emerging Pathogens Institiute
Gainesville, Florida, 32608, United States
Biospecimen
Fecal
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Volker Mai, PhD, MPH
- Organization
- University of Florida
Study Officials
- PRINCIPAL INVESTIGATOR
Volker Mai, PhD, MPH
Associate Professor
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2015
First Posted
March 2, 2015
Study Start
April 1, 2015
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
February 19, 2016
Results First Posted
February 19, 2016
Record last verified: 2016-01