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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational Chickpea Diet | Observed long-term to study legume intake and GI health (Observational Chickpea Diet) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational Chickpea Diet | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from Day 31, Day 62, and Day 93 |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals directly associated with the University of Florida (faculty, staff, students) or through the University of Florida's Health Street program.
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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 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 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. | Due to the rate of withdrawal from this study only one participant completed and this data was used for the outcome measures. | Posted | Mean | 97.5% Confidence Interval | sequences | Change from Day 31, Day 62, and Day 93 |
|
6 months
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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 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Volker Mai, PhD, MPH | University of Florida | 352-273-9398 | 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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Fecal
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| 0 |
| 12 |
| 0 |
| 12 |
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