Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Fermented Pulses on Inflammation and the Gut Microbiota

Conditions
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Fermented Food, Inflammation

Intervention / Treatment
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* Other: Unfermented chickpea
* Other: Fermented chickpea


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unfermented Chickpea<br> | Other: Unfermented chickpea<br>* Frozen meals containing 100 g unfermented chickpeas<br>|
| Experimental: Fermented Chickpea<br> | Other: Fermented chickpea<br>* Frozen meals containing 100 g fermented chickpeas<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 | Measured by fecal 16S rRNA gene sequencing | At 2 weeks (baseline), 4 weeks (after first intervention), 8 weeks (after second intervention) |