Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota

The Pennsylvania State University (PENNSTATE)

Status: Not yet enrolling

Conditions: Inflammation; Fermented Food

Treatments: Other: Unfermented chickpea; Other: Fermented chickpea

Study type: Interventional

Funder types: Other

Identifiers

NCT06134076

STUDY00023162

58-3060-3-052 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Unfermented Chickpea

Experimental group

Treatment:

Other: Unfermented chickpea

Fermented Chickpea

Experimental group

Treatment:

Other: Fermented chickpea