Status:
RECRUITING
Effect of Agricultural Practices on Crops, Gut Microbiome, and Human Health
Lead Sponsor:
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
Conditions:
Obesity Prevention
Microbiome Analysis
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief 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, whi...
Detailed Description
Objective: The primary objective of this study is to investigate the effect of differentially cultivated crops (organic versus conventional) on cardiometabolic health outcomes, as reflected by measur...
Eligibility Criteria
Inclusion
- 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
- 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, Crohn's disease, active ulcerative colitis.
- Surgery scheduled for the trial duration period.
- Pregnant or nursing women.
- Smoking or illicit drug use. Use of \>5 units of alcohol daily on average.
- History of neurological/neurodegenerative disorders.
- Participation in another concomitant clinical trial.
- Not residing in the Netherlands during study period (Sept-Nov 2025)
Key Trial Info
Start Date :
June 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 5 2027
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT07165145
Start Date
June 25 2025
End Date
July 5 2027
Last Update
September 10 2025
Active Locations (1)
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1
Amsterdam UMC, locatie AMC
Amsterdam, Amsterdam, Netherlands, 1105 AZ