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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02375373
• Other study ID #: 201400716 Long Term
• Status: Completed
• Phase: N/A
• First received: February 24, 2015
• Last updated: January 22, 2016
• Start date: April 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Inflammation

Intervention

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.

Locations

Country	Name	City	State
United States	Emerging Pathogens Institiute	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	American Pulse Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No