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
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.
Interventions
OTHERChickpea 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.
Sponsors
American Pulse Association
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
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 Diversity of Gut Microbiota 16S rRNA Gene Sequences With Regard to Time. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Chickpea Enhanced Diet |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 13 participants |
| Sex: Female, Male Female | 8 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 | 1 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
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.
Time frame: Change in Baseline (Day 1, Day 7-9, and Day 14)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chickpea Enhanced Diet | Changes in Diversity of Gut Microbiota 16S rRNA Gene Sequences With Regard to Time. | Baseline (Day 1) | 316.383 Avg. Operational Taxonomic Units | Standard Error 78.249 |
| Chickpea Enhanced Diet | Changes in Diversity of Gut Microbiota 16S rRNA Gene Sequences With Regard to Time. | Day 7-9 | 302.400 Avg. Operational Taxonomic Units | Standard Error 89.735 |
| Chickpea Enhanced Diet | Changes in Diversity of Gut Microbiota 16S rRNA Gene Sequences With Regard to Time. | Day 14 | 283.058 Avg. Operational Taxonomic Units | Standard Error 85.62 |