Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Unfermented chickpea, Fermented chickpea.
- Who it may be relevant to
- Registry conditions: Fermented Food, Inflammation. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Fermented Pulses on Inflammation and the Gut Microbiota
Overview
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.
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.
Interventions
- Other Unfermented chickpea
Frozen meals containing 100 g unfermented chickpeas - Other Fermented chickpea
Frozen meals containing 100 g fermented chickpeas
Primary outcome measures
- 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)]
Secondary outcome measures (2)
- 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)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06134076 · STUDY00023162 · 58-3060-3-052