Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2026-08-31

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:

1. How does consuming the fermented foods impact the gut microbiome?
2. 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.

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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.

Conditions

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Fermented Food Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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Unfermented Chickpea

Group Type EXPERIMENTAL

Unfermented chickpea

Intervention Type OTHER

Frozen meals containing 100 g unfermented chickpeas

Fermented Chickpea

Group Type EXPERIMENTAL

Fermented chickpea

Intervention Type OTHER

Frozen meals containing 100 g fermented chickpeas

Interventions

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Unfermented chickpea

Frozen meals containing 100 g unfermented chickpeas

Intervention Type OTHER

Fermented chickpea

Frozen meals containing 100 g fermented chickpeas

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes