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OpenTrials
Completed

NCT Number: NCT02375347

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emerging Pathogens Institiute

Gainesville, Florida, 32608, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chickpea Enhanced Diet (Short term)

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.

Other names: Go'Bonzo's

Primary outcomes

  1. Changes in Diversity of Gut Microbiota 16S rRNA Gene Sequences With Regard to Time.

    Time frame: Change in Baseline (Day 1, Day 7-9, and Day 14)

    Compare the gut microbiota composition and overall diversity 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.

    The use of Operational Taxonomic Units (OTUs) are used to classify clusters of similar bacterial groups. OTUs are species or group of species often used when only DNA sequence data is available.

    This measure is the average amount of OTUs found for each time point.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • American Pulse Association

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 2, 2015
Registry last updated
May 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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