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| Name | Class |
|---|---|
| American Pulse Association | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chickpea Enhanced Diet | Experimental | Fed an enhanced Chickpea diet over a short term period (Chickpea Enhanced Diet Short Term) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chickpea Enhanced Diet (Short term) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change in Baseline (Day 1, Day 7-9, and Day 14) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Volker Mai, PhD, MPH | Associate Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emerging Pathogens Institiute | Gainesville | Florida | 32608 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | Avg. Operational Taxonomic Units | Change in Baseline (Day 1, Day 7-9, and Day 14) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cracked Tooth | Injury, poisoning and procedural complications |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Volker Mai, PhD, MPH | University of Florida | 3522739398 | vmai@epi.ufl.edu |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 13 |
| 1 |
| 13 |
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