Impact of Fermented Pulses on Inflammation and the Gut Microbiota
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Penn State University
- Enrollment
- 30
- Primary Endpoint
- Change in inflammation levels from baseline and between interventions
Study Overview
Brief Summary
The goal of this clinical trial is to learn about the effects of consuming fermented pulses (certain types of legumes like chickpeas or lentils) in healthy people. The main questions it aims to answer are:
- How does consuming the fermented foods impact the gut microbiome?
- Does this interaction between the fermented foods and the gut microbiome affect inflammation?
Participants will be asked to consume two sets of prepared meals, one containing unfermented pulses, the other containing fermented pulses.
Researchers will compare the gut microbiome and inflammation between these two diets.
Detailed Description
The rationale for the research is that fermentation of pulses can reduce the concentration of compounds that suppress butyrate producing bacteria and butyrate production. This will in turn boost butyrate production during consumption of these fermented pulses relative to that in unfermented pulses. This in turn will lead to lower inflammation in people consuming fermented pulses. To best study this question the investigators will utilize a cross-over design trial where participants will consume daily meals containing either fermented or unfermented pulses (chickpeas), followed by a washout period and then a period of consuming the other type of pulse. The investigators hypothesize that those consuming the fermented pulses will experience a significant decrease in inflammatory markers driven by increased butyrate production by gut bacteria.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Subjects will receive both interventions labeled only as 1 or 2. The study team assessing inflammation and microbiome will not know the identity of intervention 1 or 2. The preparer of the meals will also conduct dietary recall interviews with subjects and will know the identities of the interventions.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy adults
Exclusion Criteria
- •Taken antibiotics within the past month
- •Taking any medication for the management of diabetes or obesity
- •Are pregnant
- •BMI > 24.9
- •Allergies to pulses or any other meal components
Arms & Interventions
Unfermented Chickpea
Intervention: Unfermented chickpea (Other)
Fermented Chickpea
Intervention: Fermented chickpea (Other)
Outcomes
Primary Outcomes
Change in inflammation levels from baseline and between interventions
Time Frame: At 2 weeks (baseline), 4 weeks (after first intervention), 8 weeks (after second intervention)
Measured in blood (IL-1β, IL-6, IL-10, IL-12, IFN-γ, TNF-α) and in feces (NGAL, calprotectin)
Secondary Outcomes
- Change in gut microbiome composition from baseline and between interventions(At 2 weeks (baseline), 4 weeks (after first intervention), 8 weeks (after second intervention))
- Change in fecal short chain fatty acids from baseline and between interventions(At 2 weeks (baseline), 4 weeks (after first intervention), 8 weeks (after second intervention))
Investigators
Darrell W. Cockburn, Ph.D.
Assistant Professor
Penn State University