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

• Sponsor: University of Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT02375347
• Collaborator: American Pulse Association (Other)
• Enrollment: 13
• Location: 1
• Arm: 1
• Duration (Months): 5
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammation	Other: Chickpea Enhanced Diet (Short term)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: Effects of Adding Chickpeas to the American Diet on Fecal Microbiota Composition and Markers of Inflammation
• Study Start Date: Mar 1, 2015
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chickpea Enhanced Diet Fed an enhanced Chickpea diet over a short term period (Chickpea Enhanced Diet Short Term)	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.; Other Names: Go'Bonzo's

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emerging Pathogens Institiute	Gainesville	Florida	United States	32608

Sponsors and Collaborators

• University of Florida
• American Pulse Association

Investigators

• Principal Investigator: Volker Mai, PhD, MPH, Associate Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT02375347
• Other Study ID Numbers: 201400716
• First Posted: Mar 2, 2015
• Last Update Posted: May 30, 2016
• Last Verified: May 1, 2016

• Keywords provided by University of Florida: Gut Microbiota
• Additional relevant MeSH terms: Inflammation

Study Results

Participant Flow

Arm/Group Title	Chickpea Enhanced Diet
Arm/Group Description	Fed an enhanced Chickpea diet over a short term period (Chickpea Enhanced Diet Short Term) 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.
Period Title: Overall Study
STARTED	13
COMPLETED	12
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Chickpea Enhanced Diet
Arm/Group Description	Fed an enhanced Chickpea diet over a short term period (Chickpea Enhanced Diet Short Term) 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.
Overall Participants	13
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	13 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	8 61.5%
Male	5 38.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	5 38.5%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 7.7%
White	5 38.5%
More than one race	0 0%
Unknown or Not Reported	2 15.4%
Region of Enrollment (participants) [Number]
United States	13 100%

Outcome Measures

1. Primary Outcome

Title	Changes in Diversity of Gut Microbiota 16S rRNA Gene Sequences With Regard to Time.
Description	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.
Time Frame	Change in Baseline (Day 1, Day 7-9, and Day 14)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chickpea Enhanced Diet
Arm/Group Description	Fed an enhanced Chickpea diet over a short term period (Chickpea Enhanced Diet Short Term) 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.
Measure Participants	12
Baseline (Day 1)	316.383 (78.249)
Day 7-9	302.400 (89.735)
Day 14	283.058 (85.620)

Adverse Events

Arm/Group Title	Chickpea Enhanced Diet
Arm/Group Description	Fed an enhanced Chickpea diet over a short term period (Chickpea Enhanced Diet Short Term) 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.
All Cause Mortality
	Chickpea Enhanced Diet
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Chickpea Enhanced Diet
	Affected / at Risk (%)	# Events
Total	0/13 (0%)
Other (Not Including Serious) Adverse Events
	Chickpea Enhanced Diet
	Affected / at Risk (%)	# Events
Total	1/13 (7.7%)
Injury, poisoning and procedural complications
Cracked Tooth	1/13 (7.7%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.