NCT07165145

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC) · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

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 measurements of glucose metabolism and its relation to the gut microbiome composition and function. The secondary objectives are to assess the effect of differently grown crops on gut microbiome composition and function, plasma and fecal short-chain fatty acid levels, including quantification of pesticide residues and other contaminants in blood and faeces. Additionally, changes will be evaluated in metabolomics of the blood and breath volatile organic compounds (QuinTron), as well as alterations in weight, body composition. Double-blind randomized dietary intervention study, parallel design. A total of 40 male and female volunteers will be recruited for this study, aged 18-45 years. 20 will have a normal BMI of 19-25 with no current medical conditions, while the remaining 20 will have a BMI of 28-40 with three components of Metabolic Syndrome, drug-naïve. Participants will be assigned to one of two groups for 4 weeks of dietary intervention. One group will receive produce from conventional agriculture, while the other receives produce from organic agriculture, with a specific focus on differently grown fruits and vegetables. Both groups will receive: * A weekly full meal recipe kit (6 days/week) with ingredients and instructions on preparation * A separate weekly box containing additional fruits and vegetables (6 days/week)

Conditions

• Obesity Prevention
• Microbiome Analysis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Organic Fruits and Vegetables	Dietary Intervention
DIETARY_SUPPLEMENT	Conventional Fruits and Vegetables	Dietary Intervention

Timeline

• Start date: 2025-06-25
• Primary completion: 2026-12-20
• Completion: 2027-07-05
• First posted: 2025-09-10
• Last updated: 2025-09-10

Locations

1 site across 1 country: Netherlands