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

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: NCT02375347
• Other study ID #: 201400716
• Status: Completed
• Phase: N/A
• First received: February 24, 2015
• Last updated: August 19, 2015
• Start date: March 2015
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• 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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2015
• Est. primary completion date: August 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:
• Chickpea Enhanced Diet (Short term)
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.

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 Gut microbiota composition in baseline, day 9, and day 14.	Compare the gut microbiota composition 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.	Change in Baseline, Day 9, and Day 14	No