Trial Outcomes & Findings for Effects of Adding Chickpeas to the American Diet (Long Term Study) (NCT NCT02375373)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

12 participants

Primary outcome timeframe

Change from Day 31, Day 62, and Day 93

Results posted on

2016-02-19

Participant Flow

Participant milestones

Participant milestones
Measure	Obersvational Chickpea Diet 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 Study STARTED	12
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Obersvational Chickpea Diet 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 Study Withdrawal by Subject	11

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Obersvational Chickpea Diet n=12 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Change from Day 31, Day 62, and Day 93

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

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

Outcome measures

Outcome measures
Measure	Obersvational Chickpea Diet n=1 Participants 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.
Changes in Number of 16S RNA Sequences on Days 31, Day 62, and Day 93. Day 31	49171 sequences Interval 49171.0 to 49171.0
Changes in Number of 16S RNA Sequences on Days 31, Day 62, and Day 93. Day 62	48925 sequences Interval 48925.0 to 48925.0
Changes in Number of 16S RNA Sequences on Days 31, Day 62, and Day 93. Day 93	49053 sequences Interval 49053.0 to 49053.0

Adverse Events

Obersvational Chickpea Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Volker Mai, PhD, MPH

University of Florida

Phone: 352-273-9398

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place