Impacts of Fermented Pea- and Legume-based Product on Gut Microbiota and Health (NCT06743828) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Impacts of Fermented Pea- and Legume-based Product on Gut Microbiota and Health
Finland100 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 range30 Years – 70 Years
SexALL
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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