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Recruiting
NCT05611138
Dietary Proteins: Metagenomic and Metabolomics Approaches for Human Biomarkers Identification
Conditions: Healthy
Sex: All
Ages: 18 Years – 45 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 87
Sponsor: Örebro University, Sweden
Location: Sweden
Summary
This project aims to create a methodological framework, including the discovery and validation of novel biomarker panels to decipher the impact of plant-based protein intake on health biomarkers.
Moreover, the possibility of predicting biomarkers production will be tested by a colonic in vitro fermentation study using study participants' faecal samples.
Eligibility Criteria
Inclusion Criteria:Age 18-45 yearsBody mass index (BMI) 18,5-30 kg/m2Weight stable within the previous 3 monthsMaintenance of the usual physical activity habits during the studyIntake of fibre between 15 and 25 g per day (evaluated by 3 food diaries or 24-hours recalls)OmnivoresExclusion Criteria:Acute chronic disease, inflammatory or functional gastrointestinal diseases and any other disease or disorder that could affect the outcome of the studyUse of a medication that may interfere the study outcomeEating disorderHigh protein intake (more than 15% of energy or maximum 1,2 g of protein per kg of body weight per day; evaluated by 3 food diaries or 24-hours recalls)Use of antibiotic medication during the last 3 months prior the first visitUse of antibiotic medication very early in life (e.g., asthmatic children or ear inflammation)Use of laxative or anti-diarrhoea medication within the past 3 months before the studyRegular consumption of probiotic or prebiotic product for the past 6 weeks before the studySpecial diet that is considered to affect the study participation and/or study results, for example, high protein dietsMore than 5 h of moderate-vigorous exercise per weekPregnancy or breastfeedingIntolerance to dietary supplements that will be used in the studySmokingAbuse of alcohol or drugs
Source: ClinicalTrials.gov (NCT05611138). StuddyBuddy aggregates publicly available trial information.