Actively Recruiting
MicroHealth Project: Randomized Trial Comparing Effects of Organically vs Conventionally Grown Crops on Human Gut Microbiome and Health
Led by Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC) · Updated on 2025-09-10
44
Participants Needed
1
Research Sites
28 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how different farming methods for growing fruits and vegetables, specifically organic versus conventional agriculture, affect the human gut microbiome and overall health. This study focuses on adults aged 18 to 45 years, including those with normal weight and others with metabolic syndrome components, to understand how these dietary differences influence metabolic and cardiometabolic health outcomes. Participants will be divided randomly into two groups for a 4-week dietary intervention. One group will receive organic fruits and vegetables, while the other will receive conventional produce. Each week, participants will get a meal kit with recipes and ingredients for six days, plus an additional box of fruits and vegetables, to prepare and consume at home. Throughout the study, participants will undergo various assessments including glucose monitoring, gut microbiome analysis, body composition measurements, blood and fecal tests for metabolites and pesticide residues, and breath tests. These evaluations occur at baseline, during the intervention, and at a follow-up two weeks after the intervention ends, totaling about six weeks of participation. Researchers will closely monitor changes in metabolism, microbiome function, and physical health indicators.
CONDITIONS
Brief Title
Effect of Agricultural Practices on Crops, Gut Microbiome, and Human Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy Caucasian adults aged 18 to 45 years with BMI under 25 and no medical conditions
- Adults aged 18 to 45 years with BMI between 28 and 40 and three components of Metabolic Syndrome, drug-nafve
- Men with waist circumference over 102 cm (40 inches), women with waist circumference over 88 cm (35 inches)
- Fasting plasma glucose level of 110 mg/dL (6.1 mmol/L) or higher
- Fasting insulin level of 25 bcU/mL or higher (or >16.7 pmol/L)
- HOMA-IR score of 2.5 or higher
You will not qualify if you...
- Use of antibiotics in the past 3 months or currently taking them
- Currently or previously following vegan, strictly organic, or vegetarian diets
- History of severe food allergies or intolerances to the fruits and vegetables provided
- Inability or unwillingness to collect stool samples
- Diagnosis of type 1 or type 2 diabetes
- Use of medications for type 2 diabetes such as metformin, statins, proton pump inhibitors, H2 blockers, pioglitazone, or GLP-1 receptor agonists
- Past or planned bariatric surgery or history of gallbladder removal
- History of cardiovascular disease or severe digestive tract diseases like celiac disease, Crohn's disease, or active ulcerative colitis
- Planned surgery during the study period
- Pregnant or nursing women
- Smoking, illicit drug use, or consuming more than 5 units of alcohol daily on average
- History of neurological or neurodegenerative disorders
- Participation in another clinical trial at the same time
- Not residing in the Netherlands during the study period (September to November 2025)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants follow a 4-week dietary intervention receiving either organically or conventionally grown fruits and vegetables through weekly meal kits and additional produce boxes.
Weekly visits for assessments and sample collections
Duration - 2 weeks
Participants are monitored for 2 weeks after intervention to evaluate sustained effects on gut microbiome, metabolic health, and other outcomes.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Amsterdam UMC, locatie AMC
Amsterdam, Amsterdam, Netherlands, 1105 AZ
Actively Recruiting
Research Team
M
Max Nieuwdorp, Prof., Dr.
H
Hilde H.J. Herrema, PhD.,
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
4
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