Effects of Adding Chickpeas to the American Diet (Long Term Study)

• Sponsor: University of Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT02375373
• Collaborator: American Pulse Association (Other)
• Enrollment: 12
• Location: 1
• Duration (Months): 8
• Patients Per Site Per Month: 1.5

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: Observational Chickpea Diet

Detailed Description

Long-term observational study:

Subjects enrolled will participate in an observational setting for three months. During this time period, individuals will be encouraged, to maintain increased legume intake and explore new recipes that allow them to maintain a diverse menu of legume based foods. Fecal samples for microbiota analysis will be collected every month. Participants will record a weekly online questionnaire about legume intake and GI health as well as other health status updates. While participants will be encouraged to maintain regular intake of chickpeas throughout the long-term study, consumption of other legumes will be encouraged.

Study Design

• Study Type: Observational
• Actual Enrollment: 12 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Effects of Adding Chickpeas to the American Diet on Fecal Microbiota Composition and Markers of Inflammation
• Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Observational Chickpea Diet Observed long-term to study legume intake and GI health (Observational Chickpea Diet)	Other: Observational Chickpea Diet; Individuals encouraged to maintain increased legume intake and explore new recipes that allow them to maintain a diverse menu of legume based foods. Fecal samples collected monthly.; Other Names: Go'Bonzo's

Outcome Measures

Primary Outcome Measures

1. Changes in Number of 16S RNA Sequences on Days 31, Day 62, and Day 93. [Change from Day 31, Day 62, and Day 93]

   Compare the gut microbiota composition of individual subjects before and after the implementation of a controlled and observed diet of chickpeas and legume products.

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: NCT02375373
• Other Study ID Numbers: 201400716 Long Term
• First Posted: Mar 2, 2015
• Last Update Posted: Feb 19, 2016
• Last Verified: Jan 1, 2016

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

Study Results

Participant Flow

Arm/Group Title	Obersvational Chickpea Diet
Arm/Group Description	Observed long-term to study legume intake and GI health (Observational Chickpea Diet) Observational Chickpea Diet: Individuals encouraged to maintain increased legume intake and explore new recipes that allow them to maintain a diverse menu of legume based foods. Fecal samples collected monthly.
Period Title: Overall Study
STARTED	12
COMPLETED	1
NOT COMPLETED	11

Baseline Characteristics

Arm/Group Title	Obersvational Chickpea Diet
Arm/Group Description	Observed long-term to study legume intake and GI health (Observational Chickpea Diet) Observational Chickpea Diet: Individuals encouraged to maintain increased legume intake and explore new recipes that allow them to maintain a diverse menu of legume based foods. Fecal samples collected monthly.
Overall Participants	12
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	12 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	7 58.3%
Male	5 41.7%
Region of Enrollment (participants) [Number]
United States	12 100%

Outcome Measures

1. Primary Outcome

Title	Changes in Number of 16S RNA Sequences on Days 31, Day 62, and Day 93.
Description	Compare the gut microbiota composition of individual subjects before and after the implementation of a controlled and observed diet of chickpeas and legume products.
Time Frame	Change from Day 31, Day 62, and Day 93

Outcome Measure Data

Analysis Population Description

Due to the rate of withdrawal from this study only one participant completed and this data was used for the outcome measures.

Arm/Group Title	Obersvational Chickpea Diet
Arm/Group Description	Observed long-term to study legume intake and GI health (Observational Chickpea Diet) Observational Chickpea Diet: Individuals encouraged to maintain increased legume intake and explore new recipes that allow them to maintain a diverse menu of legume based foods. Fecal samples collected monthly.
Measure Participants	1
Day 31	49171
Day 62	48925
Day 93	49053

Adverse Events

Time Frame	6 months
Arm/Group Title	Obersvational Chickpea Diet
Arm/Group Description	Observed long-term to study legume intake and GI health (Observational Chickpea Diet) Observational Chickpea Diet: Individuals encouraged to maintain increased legume intake and explore new recipes that allow them to maintain a diverse menu of legume based foods. Fecal samples collected monthly.
All Cause Mortality
	Obersvational Chickpea Diet
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Obersvational Chickpea Diet
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Other (Not Including Serious) Adverse Events
	Obersvational Chickpea Diet
	Affected / at Risk (%)	# Events
Total	0/12 (0%)

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.