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

Completed

• Conditions: Inflammation
• Interventions: Other: Observational Chickpea Diet

• Registration Number: NCT02375373
• 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

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 Timeline

• Study First Submitted: 2015-02-24
• Study First Submitted QC: 2015-02-24
• Study First Posted: 2015-03-02
• Study Start: 2015-04
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Results First Submitted: 2015-12-01
• Status Verified: 2016-01
• Results First Submitted QC: 2016-01-22
• Last Update Submitted: 2016-01-22
• Results First Posted: 2016-02-19
• Last Update Posted: 2016-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Changes in Number of 16S RNA Sequences on Days 31, Day 62, and Day 93.	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.

Trial Locations

Locations (1)

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