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

An observational study of Inflammation, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Inflammation
What is being tested?: Observational Chickpea Diet
How many people: 12 participants
Where: 1 siteUnited States
Study dates: Apr 2015to Dec 2015
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Individuals directly associated with the University of Florida (faculty, staff, students) or through the University of Florida's Health Street program.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Emerging Pathogens Institiute
Gainesville, Florida, 32608

Other trials in United States

About this study

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

Read the 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.

Conditions: Inflammation
Being tested: Observational Chickpea Diet
Keywords: Gut Microbiota
Medical subject headings: Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Observational Chickpea DietOther
Also called Go'Bonzo's
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.

Study groups in NCT02375373
Study group	Role	What they receive
Observational Chickpea Diet		Observed long-term to study legume intake and GI health (Observational Chickpea Diet) Receives: Other: Observational Chickpea Diet

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in Number of 16S RNA Sequences on Days 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.
Measured: Change from Day 31, Day 62, and Day 93

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2015Dec 2015

First posted2 Mar 2015 (estimated)
Study startApr 2015
Primary completionDec 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for InflammationStudies of the same condition, open and under way.
More trials run by University of FloridaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02375373
Sponsor's protocol ID: 201400716 Long Term
Status last verified: Jan 2016
First submitted: 24 Feb 2015
Last updated: 19 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Inflammation trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Adding Chickpeas to the American Diet on Fecal Microbiota Composition and Markers of Inflammation
ClinicalTrials.gov ID: NCT02375373
Acronym / sponsor ID: 201400716 Long Term
Conditions: Inflammation
Keywords: Gut Microbiota
Study type: Observational
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Collaborators: American Pulse Association
Study start: Apr 2015
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 2 Mar 2015 (estimated)
Results: Posted 19 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Long-term observational study:

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Observational Chickpea Diet	–	Other: Observational Chickpea DietObserved long-term to study legume intake and GI health (Observational Chickpea Diet)

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Individuals directly associated with the University of Florida (faculty, staff, students) or through the University of Florida's Health Street program.

Key inclusion criteria (4 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Observational Chickpea DietAlso: Go'Bonzo'sIndividuals 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	Observational Chickpea Diet

Primary outcome

Changes in Number of 16S RNA Sequences on Days 31, Day 62, and Day 93.
Time frame: 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.

Results and safety

Results posted to the registry on 19 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Obersvational Chickpea Diet	12	1

Primary outcome: Changes in Number of 16S RNA Sequences on Days 31, Day 62, and Day 93.

Time frame: Change from Day 31, Day 62, and Day 93. Mean (97.5% Confidence Interval). Unit: sequences

Measure	Obersvational Chickpea Diet n = 1
Day 31	49171 (49171 to 49171)
Day 62	48925 (48925 to 48925)
Day 93	49053 (49053 to 49053)

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

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Obersvational Chickpea Diet	0 of 12 (0%)	0 of 12 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Inflammation

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Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Volker Mai, PhD, MPH principal investigator

Associate Professor

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Inflammation, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Number of 16S RNA Sequences on Days 31, Day 62, and Day 93. (time frame: Change from Day 31, Day 62, and Day 93). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02375373.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2016.