CompletedNot Applicable

Effect of Agricultural Practices on Crops, Gut Microbiome, and Human Health

Netherlands44 participantsStarted 2025-06-25

Plain-language summary

The human gut microbiome plays a regulatory role in host health, and is involved in metabolic, immune, and neurological processes. Diet shapes the gut microbiome; by providing essential nutrients, which sustain the existing microorganisms and by introducing foodborne microbes that modulate its composition. Notably, the impact of microbes from fruit and vegetables on the gut microbiome is relatively unexplored. Differences in agricultural practices, organic vs conventional strategies, can lead to variations in nutritional content and associated microbial communities in and on crops, underscoring the potential for variations in cultivated crops to influence the human gut microbiome's composition and function. This study aims to explore how crop cultivation practices affect the composition and function of the human gut microbiome, ultimately influencing overall health.

Who can participate

Age range

18 Years – 45 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: * 22 Healthy Volunteers : healthy Caucasian adults with a BMI \< 25 kg/m\^2 will be recruited with no medical conditions. * 22 Metabolically Impaired Participants: Caucasian adults with a BMI ranging from 28 kg/m\^2 to 40 kg/m\^2 with three components of Metabolic Syndrome, drug-naïve: * Elevated waist circumference (WC): with men having WC \> 102 cm (40 inches) and women having a WC \> 88 cm (35 inches). * High Fasting Plasma Glucose (FPG): a fasting plasma glucose level 110 mg/dL (6.1 mmol/L) * High Fasting Plasma Insulin (FPI): A fasting insulin level ≥25 μU/mL (or \>16.7 pmol/L) * HOMA-IR score of ≥2.5 Exclusion Criteria: * Use of antibiotic in the past 3 months or currently taking them * Past/ Currently following a vegan, strictly organic or vegetarian diet. * History of severe food allergies or intolerances that would render it unsafe for them to consume any of the fruits and vegetables provided. Exclusion will be determined on a case-by-case basis by the investigator. * Inability or unwillingness to collect stools. * Presence of overt type 1 diabetes mellitus (T1DM) and/or type 2 diabetes. * Use of medications for type 2 diabetes: metformin, statin, proton pump inhibitors (PPI), H2 blockers, pioglitazone, active GLP-1 receptor agonists (e.g., exenatide, liraglutide). * Prior or planned bariatric surgery, history of cholecystectomy. * History of cardiovascular disease, having a severe disease of the digestive tract, such as celiac disease…

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.

What they're measuring

Time in Range

Timeframe: At Baseline, week 4 (End-of-intervention)

Trial details

NCT IDNCT07165145

SponsorAmsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-21

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