Clinical trial NCT06134076: Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota
Official title: Impact of Fermented Pulses on Inflammation and the Gut Microbiota
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fermented Food
Inflammation
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: United States Department of Agriculture (USDA)
First posted: 2023-11-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 2 week run-in period with no pulse consumption. Randomly assigned to order of receiving interventions. Blood sample, fecal sample, dietary recall. 2 week intervention 1. Blood sample, fecal sample, dietary recall. 2 week washout. 2 week intervention 2. Blood sample, fecal sample, dietary recall.
Primary purpose: BASIC_SCIENCE

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:

1. How does consuming the fermented foods impact the gut microbiome?
2. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in inflammation levels from baseline and between interventions
timeFrame: At 2 weeks (baseline), 4 weeks (after first intervention), 8 weeks (after second intervention)
Secondary outcomes:
measure: Change in fecal short chain fatty acids from baseline and between interventions
timeFrame: At 2 weeks (baseline), 4 weeks (after first intervention), 8 weeks (after second intervention)
measure: Change in gut microbiome composition from baseline and between interventions
timeFrame: At 2 weeks (baseline), 4 weeks (after first intervention), 8 weeks (after second intervention)
Other outcomes:
Locations:
Study officials:
affiliation: Penn State University
name: Darrell Cockburn, PhD
role: PRINCIPAL_INVESTIGATOR
References: