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Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota

Impact of Fermented Pulses on Inflammation and the Gut Microbiota

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06134076
Enrollment
30
Registered
2023-11-18
Start date
2027-09-01
Completion date
2029-08-01
Last updated
2026-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fermented Food, Inflammation

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.

Interventions

OTHERUnfermented chickpea

Frozen meals containing 100 g unfermented chickpeas

OTHERFermented chickpea

Frozen meals containing 100 g fermented chickpeas

Sponsors

Penn State University
Lead SponsorOTHER
United States Department of Agriculture (USDA)
CollaboratorFED

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, 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.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Change in inflammation levels from baseline and between interventionsAt 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

MeasureTime frameDescription
Change in fecal short chain fatty acids from baseline and between interventionsAt 2 weeks (baseline), 4 weeks (after first intervention), 8 weeks (after second intervention)Measurement of acetate, propionate and butyrate in feces
Change in gut microbiome composition from baseline and between interventionsAt 2 weeks (baseline), 4 weeks (after first intervention), 8 weeks (after second intervention)Measured by fecal 16S rRNA gene sequencing

Contacts

CONTACTDarrell W Cockburn, PhD
dwc30@psu.edu814-863-2950
CONTACTAndy Paff, MS
amp7390@psu.edu919-909-8392
PRINCIPAL_INVESTIGATORDarrell Cockburn, PhD

Penn State University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 11, 2026