Gut microbiome Gut flora
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Healthy Volunteers:European Dutch male/femaleBMI: 18-28 kg/m² Age: 18-50 yearsResident in Amsterdam areaAble to understand information and provide informed consent
Exclusion criteria
Exclusion criteria: Self-reported:Use of pre-, pro-, or synbiotics, Use of systemic antibiotics within 3 months prior to randomization.Current or recent adherence to restrictive diets (e.g., vegan, vegetarian, strictly organic).Gastrointestinal conditions or symptoms, including severe food allergies/intolerances (case-by-case), diarrhoea, haematochezia, IBS (Rome IV), chronic constipation, or major GI diseases (e.g., celiac disease, Crohn’s disease, ulcerative colitis, short bowel syndrome), or GI cancer risk.Metabolic or chronic diseases, including type 1 or type 2 diabetes, cardiovascular disease, autoimmune disorders with GI involvement, neurological/neurodegenerative disorders, or significant psychiatric/eating disorders.Use of relevant medications (e.g., antidiabetics including GLP-1 agonists, statins, PPIs, H2 blockers, pioglitazone, methotrexate, amiodarone).History of major surgeries (e.g., bariatric surgery, cholecystectomy) or planned surgery during the study period.History of invasive malignancy (unless in full remission or low-risk treated cases).Substance use, including smoking, illicit drugs, or excessive alcohol consumption (>5 units/day).Inability or unwillingness to comply with study procedures (e.g., stool collection), participation in another clinical trial, or any condition compromising safety/compliance.Not residing in the Netherlands for the full study duration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to demonstrate direct transfer of microbes from metagenomic analyzed crops (carrot and lettuce) to the human gut microbiome. Although crop-associated microbes may already be present at baseline, these will only be similar to the ones on our vegetables at higher taxonomic levels (for example at a family, genus, or species level), our analyses will be performed at the strain level. Because our analysis will be performed at the strain level we will be able to track specific strains associated with the lettuce and carrots provided by us. In addition, baseline measurements serve as a within-participant reference, enabling correction for pre-existing microbes and distinguish newly acquired ones. Specifically, we will assess the acquisition, persistence, or loss of crop-derived strains following consumption of the study vegetables. The primary outcome is a binary high strain-transfer rate endpoint (yes/no) defined as achieving a predefined threshold of newly acquired plant-derived strains relative to baseline. Secondary analyses will quantify the number and relative abundance of engrafted strains and the continuous strain-transfer rate. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective is to assess the transfer of microbial functional potential using faecal metagenomic data (e.g., taxonomic and functional annotations, bacterial strain tracking, phageome analyses, and phage–bacteria interactions), and to analyze differences between microbes associated with low-input (organic) versus high-input (conventional) crops.Both primary and secondary endpoints will be evaluated using weekly stool samples collected from participants. | — |
Countries
Netherlands
Contacts
Amsterdam UMC