Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota

NCT06134076 | Not Yet Recruiting

• 2 other identifiers: STUDY0002316258-3060-3-052
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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. 1.How does consuming the fermented foods impact the gut microbiome?
2. 2.Does this interaction between the fermented foods and the gut microbiome affect inflammation?

Conditions

Fermented Food; Inflammation

Outcome Measures

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)

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

Secondary Outcomes (2)

• 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)

• Change in gut microbiome composition from baseline and between interventions

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

Study Arms (2)

Unfermented Chickpea

EXPERIMENTAL

Other: Unfermented chickpea

Fermented Chickpea

EXPERIMENTAL

Other: Fermented chickpea

Interventions

Unfermented chickpea OTHER

Frozen meals containing 100 g unfermented chickpeas

Unfermented Chickpea

Fermented chickpea OTHER

Frozen meals containing 100 g fermented chickpeas

Fermented Chickpea

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead
• United States Department of Agriculture (USDA): collaborator

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Darrell Cockburn, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Darrell W Cockburn, PhD

CONTACT

814-863-2950; dwc30@psu.edu

Andy Paff, MS

CONTACT

919-909-8392; amp7390@psu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 18, 2023
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share