Trial Outcomes & Findings for Effects of Adding Chickpeas to the American Diet on Fecal Microbiota Composition and Markers of Inflammation (NCT NCT02375347)

Last Updated: 2016-05-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

13 participants

Primary outcome timeframe

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

Results posted on

2016-05-30

Participant Flow

Participant milestones

Participant milestones
Measure	Chickpea Enhanced Diet 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 Study STARTED	13
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Chickpea Enhanced Diet 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 Study Protocol Violation	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chickpea Enhanced Diet n=13 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Chickpea Enhanced Diet n=12 Participants 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.
Changes in Diversity of Gut Microbiota 16S rRNA Gene Sequences With Regard to Time. Baseline (Day 1)	316.383 Avg. Operational Taxonomic Units Standard Error 78.249
Changes in Diversity of Gut Microbiota 16S rRNA Gene Sequences With Regard to Time. Day 7-9	302.400 Avg. Operational Taxonomic Units Standard Error 89.735
Changes in Diversity of Gut Microbiota 16S rRNA Gene Sequences With Regard to Time. Day 14	283.058 Avg. Operational Taxonomic Units Standard Error 85.620

Adverse Events

Chickpea Enhanced Diet

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Chickpea Enhanced Diet n=13 participants at risk 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.
Injury, poisoning and procedural complications Cracked Tooth	7.7% 1/13 • Number of events 1

Additional Information

Volker Mai, PhD, MPH

University of Florida

Phone: 3522739398

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place