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

NCT07165145 | Recruiting DMC

• 1 other identifier: NL88508.018.24
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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, 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

Obesity Prevention; Microbiome Analysis

Keywords

Microbiome; Agricultural Strategies; Fruits and Vegetables; Diet; Organic and Conventional; Biological; Prevention

Outcome Measures

Primary Outcomes (1)

• Time in Range

  The primary objective of this study is to investigate the effect of deferentially cultivated crops (organic versus conventional) on glucose levels. Measured by the difference in time in range between the groups between baseline, end-of-diet intervention

  At Baseline, week 4 (End-of-intervention)

Secondary Outcomes (13)

• Continuous glucose monitoring

  Between Baseline (week-1) and End-of-intervention (week4)

• Gut microbiome

  Every week from baseline (week -1) to follow-up (week 6)

• Body Composition

  Baseline, End-of-intervention (week 4), Follow-up (week 6)

• Anthropometric measurements

  Baseline, week 4 and follow-up (week 6)

• Dietary Intake

  Baseline (week -1), End-of-Intervention (week 4), follow-up (week 6)

Study Arms (4)

A) 11 MetSyn participants

ACTIVE COMPARATOR

Organic Fruits and Vegetables

Dietary Supplement: Organic Fruits and Vegetables

B) 11 MetSyn participants

ACTIVE COMPARATOR

Conventional Fruits and Vegetables

Dietary Supplement: Conventional Fruits and Vegetables

C) 11 Healthy participants

ACTIVE COMPARATOR

Organic Fruits and Vegetables

Dietary Supplement: Organic Fruits and Vegetables

D) Healthy participants

ACTIVE COMPARATOR

Conventional Fruits and Vegetables

Dietary Supplement: Conventional Fruits and Vegetables

Interventions

Organic Fruits and Vegetables DIETARY_SUPPLEMENT

Dietary Intervention

A) 11 MetSyn participants; C) 11 Healthy participants

Conventional Fruits and Vegetables DIETARY_SUPPLEMENT

Dietary Intervention

B) 11 MetSyn participants; D) Healthy participants

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Volunteers : healthy Caucasian adults with a BMI \< 25 kg/m\^2 will be recruited with no medical conditions.
• 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

You may not qualify if:

• Use of antibiotic in the past 3 months or currently taking them
• Past/ Currently following a vegan, strictly organic or vegetarian diet.
• 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)

Sponsors & Collaborators

• Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC): lead

Study Sites (1)

Amsterdam UMC, locatie AMC

Amsterdam, Amsterdam, 1105 AZ, Netherlands

RECRUITING

MeSH Terms

Interventions

Vegetables

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Max Nieuwdorp, Dr. Prof.

  Dept of Vascular Medicine, Amsterdam UMC - AMC

  PRINCIPAL INVESTIGATOR

• Hilde H.J. Herrema, PhD

  Dept of Vascular Medicine, Amsterdam UMC - AMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Max Nieuwdorp, Prof., Dr.

CONTACT

020-5665737; m.nieuwdorp@amsterdamumc.nl

Hilde H.J. Herrema, PhD.,

CONTACT

h.j.herrema@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof., Dr.

Model Details: Study design: Double-blind randomized dietary intervention study, parallel design.

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: September 10, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): July 5, 2027
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)