Effects of Adding Chickpeas to the American Diet on Fecal Microbiota Composition and Markers of Inflammation
1 other identifier
interventional
13
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 not_applicable
Started Mar 2015
Shorter than P25 for not_applicable
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
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedFirst Posted
Study publicly available on registry
March 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedResults Posted
Study results publicly available
May 30, 2016
CompletedMay 30, 2016
May 1, 2016
5 months
February 24, 2015
November 23, 2015
May 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in Diversity of Gut Microbiota 16S rRNA Gene Sequences With Regard to Time.
Compare the gut microbiota composition and overall diversity of individual subjects before and after the implementation of a controlled and observed diet of chickpeas and legume products, using 16S ribosomal RNA (rRNA) sequencing of fecal samples. The use of Operational Taxonomic Units (OTUs) are used to classify clusters of similar bacterial groups. OTUs are species or group of species often used when only DNA sequence data is available. This measure is the average amount of OTUs found for each time point.
Change in Baseline (Day 1, Day 7-9, and Day 14)
Study Arms (1)
Chickpea Enhanced Diet
EXPERIMENTALFed an enhanced Chickpea diet over a short term period (Chickpea Enhanced Diet Short Term)
Interventions
Dry Roasted Chickpeas, 21.26 gram serving size bags, by mouth five times per week. Stool Samples collected at Day 1, Day 9, and Day 14.
Eligibility Criteria
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
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
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2015
First Posted
March 2, 2015
Study Start
March 1, 2015
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
May 30, 2016
Results First Posted
May 30, 2016
Record last verified: 2016-05