Health TrialsbyHealthPanel

Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota

ConditionsFermented FoodInflammation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPenn State University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy adults

Disqualifiers

Taken antibiotics within the past month

Taking any medication for the management of diabetes or obesity

Are pregnant

BMI > 24.9

Trial design

Design model

Crossover

Treatments tested in this trial

  • Unfermented chickpea

    Other intervention

    Frozen meals containing 100 g unfermented chickpeas

  • Fermented chickpea

    Other intervention

    Frozen meals containing 100 g fermented chickpeas

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Unfermented ChickpeaExperimental treatment 1 intervention
Group B: Fermented ChickpeaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

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

Secondary outcomes

1

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

Measurement of acetate, propionate and butyrate in feces

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

Change in gut microbiome composition from baseline and between interventions

Measured by fecal 16S rRNA gene sequencing

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Penn State University

Lead sponsor

United States Department of Agriculture (USDA)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: