Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota

Sponsor

Penn State University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06134076

Collaborator

USDA ARS (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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:

How does consuming the fermented foods impact the gut microbiome?
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	Intervention/Treatment	Phase
Fermented Food Inflammation	Other: Unfermented chickpea Other: Fermented chickpea	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

2 week run-in period with no pulse consumption. Randomly assigned to order of receiving interventions. Blood sample, fecal sample, dietary recall. 2 week intervention 1. Blood sample, fecal sample, dietary recall. 2 week washout. 2 week intervention 2. Blood sample, fecal sample, dietary recall.2 week run-in period with no pulse consumption. Randomly assigned to order of receiving interventions. Blood sample, fecal sample, dietary recall. 2 week intervention 1. Blood sample, fecal sample, dietary recall. 2 week washout. 2 week intervention 2. Blood sample, fecal sample, dietary recall.

Masking:

Double (Participant, Outcomes Assessor)

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

Anticipated Study Start Date :

Sep 1, 2025

Anticipated Primary Completion Date :

Aug 1, 2026

Anticipated Study Completion Date :

Aug 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Unfermented Chickpea	Other: Unfermented chickpea Frozen meals containing 100 g unfermented chickpeas
Experimental: Fermented Chickpea	Other: Fermented chickpea Frozen meals containing 100 g fermented chickpeas

Arm

Intervention/Treatment

Experimental: Unfermented Chickpea

Other: Unfermented chickpea

Frozen meals containing 100 g unfermented chickpeas

Experimental: Fermented Chickpea

Other: Fermented chickpea

Frozen meals containing 100 g fermented chickpeas

Outcome Measures

Primary Outcome Measures

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

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Penn State University
USDA ARS

Investigators

Principal Investigator: Darrell Cockburn, PhD, Penn State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Darrell W. Cockburn, Ph.D., Assistant Professor, Penn State University

ClinicalTrials.gov Identifier:

NCT06134076

Other Study ID Numbers:

STUDY00023162
58-3060-3-052

First Posted:

Nov 18, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Inflammation

Study Results

No Results Posted as of Nov 18, 2023