Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota

Inflammation Clinical Trial

Official title:

Impact of Fermented Pulses on Inflammation and the Gut Microbiota

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06134076
• Other study ID #: STUDY00023162
• Secondary ID: 58-3060-3-052
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2025
• Est. completion date: August 2026

Study information

• Verified date: November 2023
• Source: Penn State University
• Contact: Darrell W Cockburn, PhD
• Phone: 814-863-2950
• Email: dwc30[@]psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation

Intervention

Other:
• Unfermented chickpea
Frozen meals containing 100 g unfermented chickpeas
• Fermented chickpea
Frozen meals containing 100 g fermented chickpeas

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	USDA ARS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in inflammation levels from baseline and between interventions	Measured in blood (IL-1ß, IL-6, IL-10, IL-12, IFN-?, TNF-a) and in feces (NGAL, calprotectin)	At 2 weeks (baseline), 4 weeks (after first intervention), 8 weeks (after second intervention)
Secondary	Change in fecal short chain fatty acids from baseline and between interventions	Measurement of acetate, propionate and butyrate in feces	At 2 weeks (baseline), 4 weeks (after first intervention), 8 weeks (after second intervention)
Secondary	Change in gut microbiome composition from baseline and between interventions	Measured by fecal 16S rRNA gene sequencing	At 2 weeks (baseline), 4 weeks (after first intervention), 8 weeks (after second intervention)