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

NCT ID: NCT02375347

Last Updated: 2016-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2015-08-31

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.

Conditions

Inflammation

Keywords

Gut Microbiota

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Chickpea Enhanced Diet

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

Group Type: EXPERIMENTAL

Chickpea Enhanced Diet (Short term)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Go'Bonzo's

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Pulse Association

OTHER

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Volker Mai, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

Emerging Pathogens Institiute

Gainesville, Florida, United States

Countries

United States

Other Identifiers

201400716

Identifier Type: -

Identifier Source: org_study_id