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

Not Applicable

Completed

• Conditions: Inflammation
• Interventions: Other: Chickpea Enhanced Diet (Short term)

• Registration Number: NCT02375347
• Lead Sponsor: University of Florida

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.

Detailed Description

Short-term active feeding study:

The investigators will provide various chickpea products to participants for a 14 day chickpea enhanced diet. Subjects will receive specific meal plan instructions for the consumption of 5 servings/week of chickpeas. Chickpea products will be sourced from commercial providers. While participants will be told to substitute chickpea products for other diet ingredients, the subjects will be free to choose what to substitute according to their preferences. Subjects will keep daily food records and will be told that chickpea consumption will be monitored in their fecal samples (qPCR). Fecal samples will be collected before the start (Day 1), during (Day 7-9) and at the end (Day 14) of the intervention using a stool collection kit (Sigma). Participants will complete our GI health questionnaire on a weekly basis to determine tolerance to increased chickpea intake. An open ended questionnaire will be administered after participants have completed the short-term study protocol to assess any issues with compliance to chickpea intake. All individuals that increased their chickpea intake from their usual diet by at least 3 servings/week will be included in the analysis.

Study Timeline

• Study First Submitted: 2015-02-24
• Study First Submitted QC: 2015-02-24
• Study Start: 2015-03
• Study First Posted: 2015-03-02
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Results First Submitted: 2015-11-23
• Status Verified: 2016-05
• Results First Submitted QC: 2016-05-24
• Last Update Submitted: 2016-05-24
• Results First Posted: 2016-05-30
• Last Update Posted: 2016-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chickpea Enhanced Diet	Chickpea Enhanced Diet (Short term)	Fed an enhanced Chickpea diet over a short term period (Chickpea Enhanced Diet Short Term)

Primary Outcome Measures

Name	Time	Method
Changes in Diversity of Gut Microbiota 16S rRNA Gene Sequences With Regard to Time.	Change in Baseline (Day 1, Day 7-9, and Day 14)	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.

Trial Locations

Locations (1)

Emerging Pathogens Institiute; 🇺🇸 Gainesville, Florida, United States