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NCT06134076 | NOT YET RECRUITING | Fermented Food


Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota
Sponsor:

Penn State University

Information provided by (Responsible Party):

Darrell W. Cockburn, Ph.D.

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.

Condition or disease

Fermented Food

Inflammation

Intervention/treatment

Unfermented chickpea

Fermented chickpea

Phase

NA

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
Estimated Enrollment : 30 participants
Masking : DOUBLE
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.
Primary Purpose : BASIC_SCIENCE
Official Title : Impact of Fermented Pulses on Inflammation and the Gut Microbiota
Actual Study Start Date : 2025-09
Estimated Primary Completion Date : 2026-08
Estimated Study Completion Date : 2026-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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

Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota

Location Details

NCT06134076


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