NCT07165145Completed
Effect of Agricultural Practices on Crops, Gut Microbiome, and Human Health
MicroHealth Project: Human Trial A A Randomized Comparative Trial to Examine the Impact of Organically vs Conventionally Grown Crops on the Human Gut Microbiome and Health
Source: ClinicalTrials.gov · Last updated 23 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 44 (actual)
- First submitted
- 24 Jun 2025
- Start date
- 25 Jun 2025
- Primary completion date
- 21 Nov 2025
- Lead sponsor
- Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
- Diseases
- Obesity
- NCT number
- NCT07165145
What you commit to
- Study type: Interventional
- Participants enrolled: 44
- From 25 Jun 2025 to the primary completion date, 21 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of antibiotic in the past 3 months or currently taking them
- Prior or planned bariatric surgery, history of cholecystectomy.
- Surgery scheduled for the trial duration period.
- Smoking or illicit drug use. Use of \>5 units of alcohol daily on average.
- Participation in another concomitant clinical trial.
Other illness
- 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.
- 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).
- History of cardiovascular disease, having a severe disease of the digestive tract, such as celiac disease, Crohn's disease, active ulcerative colitis.
- History of neurological/neurodegenerative disorders.
Other
- Past/ Currently following a vegan, strictly organic or vegetarian diet.
- Inability or unwillingness to collect stools.
- Pregnant or nursing women.
- Not residing in the Netherlands during study period (Sept-Nov 2025)
Who the study is looking for
- 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
Age in the registry: 18 years to 45 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC, locatie AMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.