Comparing Effects of Fermented and Unfermented Pulses and... | NCT06134076

Studies
Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota

NCT06134076

Sponsor

Penn State University

Status

Not yet recruiting

Last Update Posted

Jul 10, 2026Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Fermented Food
Inflammation

Interventions

Unfermented chickpea
Fermented chickpea

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
58-3060-3-052	Other Grant/Funding Number	USDA ARS

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2027Estimated

Primary Completion Date

Aug 2028Estimated

Completion Date

Aug 2029Estimated

First Submitted Date

Nov 7, 2023

First Submission Date that Met QC Criteria

Nov 10, 2023

First Posted Date

Nov 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2026

Last Update Posted Date

Jul 10, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Darrell W. Cockburn, Ph.D., Assistant Professor, Penn State UniversityPrincipal Investigator

Lead Sponsor

Penn State UniversityOTHER

Collaborators

Name	Class
United States Department of Agriculture (USDA)	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Unfermented Chickpea	Experimental		Other: Unfermented chickpea
Fermented Chickpea	Experimental		Other: Fermented chickpea

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Unfermented chickpea	Other	Frozen meals containing 100 g unfermented chickpeas	Unfermented Chickpea

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)	At 2 weeks (baseline), 4 weeks (after first intervention), 8 weeks (after second intervention)

Secondary Outcomes

Measure	Description	Time Frame
Change in fecal short chain fatty acids from baseline and between interventions	Measurement of acetate, propionate and butyrate in feces	At 2 weeks (baseline), 4 weeks (after first intervention), 8 weeks (after second intervention)
Change in gut microbiome composition from baseline and between interventions

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Darrell W Cockburn, PhD	Contact	814-863-2950		dwc30@psu.edu
Andy Paff, MS	Contact	919-909-8392		amp7390@psu.edu

Overall Officials

Name	Affiliation	Role
Darrell Cockburn, PhD	Penn State University	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

There is no plan to make IPD available to other researchers, only summarized data

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007249	Inflammation

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

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.

Masking Info

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.

Who Masked

ParticipantOutcomes Assessor