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NCT Number: NCT06134076

Comparing Effects of Fermented and Unfermented Pulses and 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.

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Key information

Conditions

Fermented Food Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Unfermented chickpea

Other

Frozen meals containing 100 g unfermented chickpeas

Fermented chickpea

Other

Frozen meals containing 100 g fermented chickpeas

Primary outcomes

  1. Change in inflammation levels from baseline and between interventions

    Time frame: 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 outcomes

  1. Change in fecal short chain fatty acids from baseline and between interventions

    Time frame: At 2 weeks (baseline), 4 weeks (after first intervention), 8 weeks (after second intervention)

    Measurement of acetate, propionate and butyrate in feces

  2. Change in gut microbiome composition from baseline and between interventions

    Time frame: At 2 weeks (baseline), 4 weeks (after first intervention), 8 weeks (after second intervention)

    Measured by fecal 16S rRNA gene sequencing

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • United States Department of Agriculture (USDA)

Registry information

Official study title

Impact of Fermented Pulses on Inflammation and the Gut Microbiota

Important dates

Study start
2027
Primary completion
2028
Study completion
2029
First posted
Nov 18, 2023
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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