N/A N=191 Randomized Single-blind Other

Organic Diet Intervention in Primary School Children

Oxidative Stress · Inflammation

Bottom Line

View on ClinicalTrials.gov: NCT02998203 ↗

Enrolled (actual)

191

Serious AEs

—

Results posted

Sep 2023

Primary outcome: Primary: Change in Pesticide Metabolite 3-phenoxybenzoic Acid (3-PBA) Levels in Urine Between Organic and Conventional Periods* — 11.4 % change — p=<0.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Organic diet (Dietary_supplement)
Age: Pediatric · 10+ yrs
Sex: All
Sponsor: Cyprus University of Technology
Primary completion: Apr 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Pesticide Metabolite 3-phenoxybenzoic Acid (3-PBA) Levels in Urine Between Organic and Conventional Periods*	11.4	<0.001 sig
PRIMARY Overall Difference in Median 3-PBA Levels in Urine Between the Conventional and Organic Periods*	2088; 576	<0.001 sig
PRIMARY Effect of Organic Treatment in 3-PBA Levels in Urine, Taking in Account the Repeated Measures and Duration of Organic Period	-1.214	<0.001 sig
PRIMARY Overall Difference in Median 6-chloronicotininc Acid (6-CN) Levels in Urine Between the Conventional and Organic Periods*	26; 20	0.017 sig
PRIMARY Effect of Organic Treatment in 6-CN Levels in Urine, Taking in Account the Repeated Measures and Duration of Organic Period - Odds Ratio Calculated Based on the Fit of a Logistic Mixed-effect Model	0.651	0.014 sig
SECONDARY Change in Oxidative Stress/Inflammation Biomarker 8-OHdG Levels in Urine Between Organic and Conventional Periods*	1.7	0.167
SECONDARY Overall Difference in Median 8-OHdG Levels in Urine Between the Conventional and Organic Periods*	323; 296	0.07
SECONDARY Effect of Organic Treatment in 8-OHdG Levels in Urine, Taking in Account the Repeated Measures and Duration of Organic Period	-0.119	0.014 sig
SECONDARY Change in Oxidative Stress/Inflammation Biomarker 8-iso-PGF2a Levels in Urine Between Organic and Conventional Periods*	1.6	0.023 sig
SECONDARY Overall Difference in Median 8-iso-PGF2a Levels in Urine Between the Conventional and Organic Periods*	2964; 3028	0.259
SECONDARY Effect of Organic Treatment in 8-iso-PGF2a Levels in Urine, Taking in Account the Repeated Measures and Duration of Organic Period	0.408	<0.001 sig
SECONDARY Change in Oxidative Stress/Inflammation Biomarker MDA Levels in Urine Between Organic and Conventional Periods*	0.1	0.913
SECONDARY Overall Difference in Median MDA Levels in Urine Between the Conventional and Organic Periods*	858; 846	0.338
SECONDARY Effect of Organic Treatment in MDA Levels in Urine, Taking in Account the Repeated Measures and Duration of Organic Period	0.189	0.001 sig

Summary

The study aims to evaluate the hypothesized benefits of a systematic organic diet for children, over those of a conventional diet. The specific objectives of this study are to: i) Demonstrate the decreased body burden of pesticides for those children consuming an organic diet, and ii) Evaluate the effects in specific biomarkers of inflammation and oxidative stress in children systematically consuming an organic diet.

Eligibility Criteria

Inclusion Criteria

Healthy children aged 10-12 years, residing in Cyprus over the last five years who consume primarily (> 80%) conventional food (non-organic).

Exclusion Criteria

Children with chronic conditions (e.g. diabetes, asthma) or allergies in food (e.g. gluten, lactose tolerance)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02998203). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.