Clinical trial NCT02375347: Effects of Adding Chickpeas to the American Diet on Fecal Microbiota Composition and Markers of Inflammation
Official title: Effects of Adding Chickpeas to the American Diet on Fecal Microbiota Composition and Markers of Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Keywords: Gut Microbiota
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: American Pulse Association
First posted: 2015-03-02
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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.

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

Primary outcomes:
measure: Changes in Diversity of Gut Microbiota 16S rRNA Gene Sequences With Regard to Time.
timeFrame: Change in Baseline (Day 1, Day 7-9, and Day 14)
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Emerging Pathogens Institiute
state: Florida
Study officials:
affiliation: Associate Professor
name: Volker Mai, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: