Impacts of Fermented Pea- and Legume-based Product on Gut Microbiota and Health (NCT06743828) | Clinical Trial Compass
CompletedNot Applicable
Impacts of Fermented Pea- and Legume-based Product on Gut Microbiota and Health
Finland56 participantsStarted 2025-01-14
Plain-language summary
This study aims to investigate the effects of consuming fermented pea- and legume-based product on gut and overall human health. It is a randomized, single-blinded, controlled, cross-over trial with a dietary intervention.
A total of 100 participants will be enrolled in this study and they will eat both fermented and unfermented pea- and legume-based products for three weeks. Participants will eat their habitual diet between the dietary intervention periods (wash-out).
During the study, participants' perceived health, inflammatory markers, glucose and lipid metabolism, tryptophan metabolites, gastrointestinal symptoms, and gut microbiota will be assessed.
Who can participate
Age range
30 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Waist circumference \>90 cm (women) or \>100 cm (men) OR BMI 27-35 kg/m2
* One of the following:
* raised blood pressure (systolic ≥ 130 mmHg and/or diastolic 85 mmHg)
* raised fasting plasma glucose (≥ 5.6 mmol/l)
* raised triglycerides (≥ 1.7 mmol/l)
* raised total cholesterol (≥ 5 mmol/l)
* raised LDL (≥ 3 mmol/l)
* reduced HDL (women \< 1.3 mmol/l, men 1.0 mmol/l)
* Consumption of at least one meal where the main protein source is meat, fish, or meat alternative on most days
* Willingness to follow intervention diets for the whole study
Exclusion Criteria:
* Diagnosed chronic diseases and conditions which could hamper the adherence to the dietary intervention protocol, e.g., type 1 or 2 diabetes, chronic liver, thyroid, kidney, or gastrointestinal diseases
* Pregnancy and lactation
* Gluten-free or vegan diet
* Recent use of antibiotics (within 3 months)
* Gastrointestinal surgery (within 6 months)
* Alcohol abuse (AUDIT ≥ 15 p and measures of liver function)
* regular smoking or use of snus or nicotine bags
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.