Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
All Genders
Healthy Volunteers
NCT07165145

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

Led by Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC) · Updated on 2025-09-10

44

Participants Needed

1

Research Sites

105 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 45Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy Caucasian adults aged 18 to 45 years with BMI less than 25 kg/m2 and no medical conditions
  • Caucasian adults aged 18 to 45 years with BMI between 28 to 40 kg/m2 having three components of Metabolic Syndrome and drug-nafve
  • Elevated waist circumference (>102 cm for men, >88 cm for women)
  • High fasting plasma glucose level (≥110 mg/dL or 6.1 mmol/L)
  • High fasting plasma insulin level (≥25 bcU/mL or >16.7 pmol/L)
  • HOMA-IR score of 2.5 or higher
Not Eligible

You will not qualify if you...

  • Use of antibiotics within the past 3 months or current use
  • Currently or previously following vegan, strictly organic, or vegetarian diets
  • Severe food allergies or intolerances that prevent consuming the provided fruits and vegetables
  • Unable or unwilling to collect stool samples
  • Presence of type 1 or type 2 diabetes
  • Use of medications for type 2 diabetes including metformin, statins, proton pump inhibitors, H2 blockers, pioglitazone, or GLP-1 receptor agonists
  • Prior or planned bariatric surgery or history of cholecystectomy
  • History of cardiovascular disease or severe digestive diseases such as celiac disease, Crohn's disease, or active ulcerative colitis
  • Scheduled surgery during the study period
  • Pregnant or breastfeeding 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 during the study
  • Not residing in the Netherlands during September to November 2025

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Amsterdam UMC, locatie AMC

Amsterdam, Amsterdam, Netherlands, 1105 AZ

Actively Recruiting

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Research Team

M

Max Nieuwdorp, Prof., Dr.

CONTACT

H

Hilde H.J. Herrema, PhD.,

CONTACT

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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