Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota

Impact of Fermented Pulses on Inflammation and the Gut Microbiota

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Inflammation; Fermented Food
• Intervention / Treatment: Other: Unfermented chickpea; Other: Fermented chickpea

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Darrell W Cockburn, PhD; Phone Number: 814-863-2950; Email: dwc30@psu.edu
• Study Contact Backup: Name: Andy Paff, MS; Phone Number: 919-909-8392; Email: amp7390@psu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Unfermented Chickpea	Other: Unfermented chickpea; Frozen meals containing 100 g unfermented chickpeas
Experimental: Fermented Chickpea	Other: Fermented chickpea; Frozen meals containing 100 g fermented chickpeas

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in inflammation levels from baseline and between interventions	Measured in blood (IL-1β, IL-6, IL-10, IL-12, IFN-γ, TNF-α) and in feces (NGAL, calprotectin)	At 2 weeks (baseline), 4 weeks (after first intervention), 8 weeks (after second intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Penn State University
• Collaborators: USDA ARS
• Investigators: Principal Investigator: Darrell Cockburn, PhD, Penn State University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: November 7, 2023
• First Submitted That Met QC Criteria: November 10, 2023
• First Posted (Estimated): November 16, 2023

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: STUDY00023162; 58-3060-3-052 (Other Grant/Funding Number: USDA ARS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make IPD available to other researchers, only summarized data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No