Fermented FoodNCT06134076
Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota
A study testing Unfermented chickpea and Fermented chickpea in people with Fermented Food and Inflammation, run by Penn State University.
Trial 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. How does consuming the fermented foods impact the gut microbiome? 2. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fermented Food, Inflammation
- What is being tested?
- Unfermented chickpea and Fermented chickpea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2027to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Fermented Pulses on Inflammation and the Gut Microbiota
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.
Read the 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.
- Conditions
- Fermented Food, Inflammation
- Being tested
- Unfermented chickpea, Fermented chickpea
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unfermented chickpeaOther
Frozen meals containing 100 g unfermented chickpeas
Fermented chickpeaOther
Frozen meals containing 100 g fermented chickpeas
| Study group | Role | What they receive |
|---|---|---|
| Unfermented Chickpea | Experimental | Not described Receives: Other: Unfermented chickpea |
| Fermented Chickpea | Experimental | Not described Receives: Other: Fermented chickpea |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measurement of acetate, propionate and butyrate in feces
Measured: At 2 weeks (baseline), 4 weeks (after first intervention), 8 weeks (after second intervention)
Change in gut microbiome composition from baseline and between interventions
Measured by fecal 16S rRNA gene sequencing
Measured: At 2 weeks (baseline), 4 weeks (after first intervention), 8 weeks (after second intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study startSep 2027 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fermented FoodStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Responsible party
- Principal investigator, Darrell W. Cockburn, Ph.D., Penn State University
- Investigators
- Darrell Cockburn, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134076
- Sponsor's protocol ID
- STUDY00023162
- Other IDs
- 58-3060-3-052
- Status last verified
- Jul 2026
- First submitted
- 7 Nov 2023
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available to other researchers, only summarized data
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Fermented Pulses on Inflammation and the Gut Microbiota
- ClinicalTrials.gov ID
- NCT06134076
- Acronym / sponsor ID
- STUDY00023162
- Conditions
- Fermented Food, Inflammation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Study start
- Sep 2027 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Unfermented Chickpea | Experimental | Other: Unfermented chickpea |
| Fermented Chickpea | Experimental | Other: Fermented chickpea |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unfermented chickpeaFrozen meals containing 100 g unfermented chickpeas | Other | Unfermented Chickpea |
| Fermented chickpeaFrozen meals containing 100 g fermented chickpeas | Other | Fermented Chickpea |
Primary outcome
Change in inflammation levels from baseline and between interventions
Time frame: 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)
2 secondary outcomes
Change in fecal short chain fatty acids from baseline and between interventions
Time frame: At 2 weeks (baseline), 4 weeks (after first intervention), 8 weeks (after second intervention)
Change in gut microbiome composition from baseline and between interventions
Time frame: At 2 weeks (baseline), 4 weeks (after first intervention), 8 weeks (after second intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No. There is no plan to make IPD available to other researchers, only summarized data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Darrell Cockburn, PhD principal investigator
Penn State University
Questions about this trial
What is this clinical trial studying?
A study testing Unfermented chickpea and Fermented chickpea in people with Fermented Food and Inflammation, run by Penn State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Darrell W Cockburn, PhD (814-863-2950, dwc30@psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in inflammation levels from baseline and between interventions (time frame: At 2 weeks (baseline), 4 weeks (after first intervention), 8 weeks (after second intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.