InflammationNCT02375347
Effects of Adding Chickpeas to the American Diet on Fecal Microbiota Composition and Markers of Inflammation
A study testing Chickpea Enhanced Diet (Short term) in people with Inflammation, run by University of Florida at 1 site in United States.
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?
- Chickpea Enhanced Diet (Short term)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Aug 2015
- Phase
- Interventional
- 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
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
About this study
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 the 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.
- Conditions
- Inflammation
- Being tested
- Chickpea Enhanced Diet (Short term)
- 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.
Chickpea Enhanced Diet (Short term)Other
Also called Go'Bonzo's
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.
| Study group | Role | What they receive |
|---|---|---|
| Chickpea Enhanced Diet | Experimental | Fed an enhanced Chickpea diet over a short term period (Chickpea Enhanced Diet Short Term) Receives: Other: Chickpea Enhanced Diet (Short term) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Diversity of Gut Microbiota 16S rRNA Gene Sequences With Regard to Time.
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.
Measured: Change in Baseline (Day 1, Day 7-9, and Day 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionAug 2015
- Study completionAug 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- American Pulse Association
- Responsible party
- Sponsor
- Investigators
- Volker Mai, PhD, MPH, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375347
- Sponsor's protocol ID
- 201400716
- Status last verified
- May 2016
- First submitted
- 24 Feb 2015
- Last updated
- 30 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 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
- NCT02375347
- Acronym / sponsor ID
- 201400716
- Conditions
- Inflammation
- Keywords
- Gut Microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- American Pulse Association
- Study start
- Mar 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 2 Mar 2015 (estimated)
- Results
- Posted 30 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chickpea Enhanced Diet | Experimental | Other: Chickpea Enhanced Diet (Short term)Fed an enhanced Chickpea diet over a short term period (Chickpea Enhanced Diet Short Term) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Chickpea Enhanced Diet (Short term)Also: Go'Bonzo'sDry 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 | Chickpea Enhanced Diet |
Primary outcome
Changes in Diversity of Gut Microbiota 16S rRNA Gene Sequences With Regard to Time.
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Inflammation
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
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
Head and Neck Cancer (H&N)
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
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?
A study testing Chickpea Enhanced Diet (Short term) in people with 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 30 May 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 30 May 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 Diversity of Gut Microbiota 16S rRNA Gene Sequences With Regard to Time. (time frame: Change in Baseline (Day 1, Day 7-9, and Day 14)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2016.