Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota

Not Applicable

Not yet recruiting

• Conditions: Fermented Food; Inflammation
• Interventions: Other: Fermented chickpea; Other: Unfermented chickpea

• Registration Number: NCT06134076
• Lead Sponsor: Penn State University

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.

Study Timeline

• Study First Submitted: 2023-11-07
• Study First Submitted QC: 2023-11-10
• Study First Posted: 2023-11-18
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-20
• Study Start: 2025-09
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fermented Chickpea	Fermented chickpea	-
Unfermented Chickpea	Unfermented chickpea	-

Primary Outcome Measures

Name	Time	Method
Change in inflammation levels from baseline and between interventions	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 Outcome Measures

Name	Time	Method
Change in gut microbiome composition from baseline and between interventions	At 2 weeks (baseline), 4 weeks (after first intervention), 8 weeks (after second intervention)	Measured by fecal 16S rRNA gene sequencing
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)	Measurement of acetate, propionate and butyrate in feces