Inflammation
Conditions
Keywords
Gut Microbiota
Brief 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.
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.
Interventions
OTHERObservational 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.
Sponsors
American Pulse Association
University of Florida
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Number of 16S RNA Sequences on Days 31, Day 62, and Day 93. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 11 |
Baseline characteristics
| Characteristic | Obersvational Chickpea Diet |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Obersvational Chickpea Diet | Changes in Number of 16S RNA Sequences on Days 31, Day 62, and Day 93. | Day 31 | 49171 sequences |
| Obersvational Chickpea Diet | Changes in Number of 16S RNA Sequences on Days 31, Day 62, and Day 93. | Day 62 | 48925 sequences |
| Obersvational Chickpea Diet | Changes in Number of 16S RNA Sequences on Days 31, Day 62, and Day 93. | Day 93 | 49053 sequences |