NCT02998203: ORGANIKO

Organic Diet Intervention in Primary School Children

Completed NA Results posted Last updated 7 September 2023

What this trial tests

NA trial testing Organic diet in Oxidative Stress in 191 participants. Completed in 18 April 2017.

Timeline

3 January 2017

Primary endpoint
18 April 2017

18 April 2017

Quick facts

Lead sponsor	Cyprus University of Technology
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	other
Enrollment	191
Start date	3 January 2017
Primary completion	18 April 2017
Estimated completion	18 April 2017

Drugs / interventions tested

• Organic diet

Conditions studied

• Oxidative Stress — all drugs for Oxidative Stress →
• Inflammation — all drugs for Inflammation →

Sponsor

Cyprus University of Technology

Who can join

Adults 10 to 12, any sex, with Oxidative Stress or Inflammation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Pesticide Metabolite 3-phenoxybenzoic Acid (3-PBA) Levels in Urine Between Organic and Conventional Periods* Primary · Last sample of the conventional period and the last sample of organic period, up to 40 days for each period

Percent change in pesticide metabolite 3-phenoxybenzoic acid (3-PBA) levels between the last sample of the conventional treatment period (before the start of the organic treatment) and the last sample of organic treatment period. A one-sample t-test was used to assess whether the percent change was different than zero. \*Note: This test does not take into account the repeated measures for each participant and the organic treatment duration. The results of the linear-mixed effect models are the ones considered (reported in a section below) as they take into account the repeated measures for ea

Group	Value	95% CI
% Change in 3-PBA Between Last Sample of Conventional Period and Last Sample of Organic Period	11.4	5.7 – 17.2

Overall Difference in Median 3-PBA Levels in Urine Between the Conventional and Organic Periods* Primary · 1 baseline sample, 2 samples in the conventional period (typical conventional diet) and 3 samples in the organic period, up to 40 days for each Period

Overall difference in median 3-PBA levels between the conventional and organic periods. The overall differences in the medians of biomarkers between the conventional and the organic phase were assessed with the non-parametric Wilcoxon rank sum test on the creatinine-adjusted concentrations pooling all conventional samples (including the baseline) and the organic samples for all participants, regardless of the duration for which they followed the organic treatment. \*Note: This test does not take into account the repeated measures for each participant and the organic treatment duration. The re

Group	Value	95% CI
Median 3-PBA Levels in the Conventional Period	2088	689 – 5273
Median 3-PBA Levels in the Organic Period	576	164 – 1681

Effect of Organic Treatment in 3-PBA Levels in Urine, Taking in Account the Repeated Measures and Duration of Organic Period Primary · 1 baseline sample, 2 samples in the conventional period (typical conventional diet) and 3 samples in the organic period, up to 40 days for each Period

A linear mixed-effect regression model was fitted for 3-PBA (log-transformed, creatinine-adjusted). The model accounted for the duration and the effect of treatment. It included student-level (repeated measures within person) and school-level (multiple students clustered within each school) random intercepts with an unstructured covariance matrix. Continuous variables, other than time (days of treatment), were centered at the population means. The model included fixed effects for treatment condition (organic or conventional) and time (days of treatment), where time = 0 was used for the start o

Group	Value	95% CI
Linear Mixed-effect Model of Log-transformed Pesticide Metabolite 3-PBA	-1.214	-1.44 – -0.987

Overall Difference in Median 6-chloronicotininc Acid (6-CN) Levels in Urine Between the Conventional and Organic Periods* Primary · 1 baseline sample, 2 samples in the conventional period (typical conventional diet) and 3 samples in the organic period, up to 40 days for each Period

Overall difference in median 6-CN levels between the conventional and organic periods. The overall differences in the medians of biomarkers between the conventional and the organic phase were assessed with the non-parametric Wilcoxon rank sum test on the creatinine-adjusted concentrations pooling all conventional samples (including the baseline) and the organic samples for all participants, regardless of the duration for which they followed the organic treatment. \*Note: This test does not take into account the repeated measures for each participant and the organic treatment duration. The res

Group	Value	95% CI
Median 6-CN Levels in the Conventional Period	26	6 – 180
Median 6-CN Levels in the Organic Period	20	5 – 79

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 Primary · 1 baseline sample, 2 samples in the conventional period (typical conventional diet) and 3 samples in the organic period, up to 40 days for each Period

A logistic model was fitted for 6-CN (binary variable; above and below LOD) due to the high number of values below LOD. The model accounted for the duration and the effect of treatment. It included student-level (repeated measures within person) and school-level (multiple students clustered within each school) random intercepts with an unstructured covariance matrix. Continuous variables, other than time (days of treatment), were centered at the population means. The model included fixed effects for treatment condition (organic or conventional) and time (days of treatment), where time = 0 was

Group	Value	95% CI
Logistic Mixed-effect Model of Pesticide Metabolite 6-CN	0.651	0.463 – 0.917

Change in Oxidative Stress/Inflammation Biomarker 8-OHdG Levels in Urine Between Organic and Conventional Periods* Secondary · Last sample of the conventional period and the last sample of organic period, up to 40 days for each period

Percent change in oxidative stress/inflammation biomarker 8-OHdG levels between the last sample of the conventional treatment period (before the start of the organic treatment) and the last sample of organic treatment period. A one-sample t-test was used to assess whether the percent change was different than zero. \*Note: This test does not take into account the repeated measures for each participant and the organic treatment duration. The results of the linear-mixed effect models are the ones considered (reported in a section below) as they take into account the repeated measures for each p

Group	Value	95% CI
% Change in 8-OHdG Between Last Sample of Conventional Period and Last Sample of Organic Period	1.7	-0.7 – 4

Overall Difference in Median 8-OHdG Levels in Urine Between the Conventional and Organic Periods* Secondary · 1 baseline sample, 2 samples in the conventional period (typical conventional diet) and 3 samples in the organic period, up to 40 days for each Period

Overall difference in median 8-OHdG levels between the conventional and organic periods. The overall differences in the medians of biomarkers between the conventional and the organic phase were assessed with the non-parametric Wilcoxon rank sum test on the creatinine-adjusted concentrations pooling all conventional samples (including the baseline) and the organic samples for all participants, regardless of the duration for which they followed the organic treatment. \*Note: This test does not take into account the repeated measures for each participant and the organic treatment duration. The r

Group	Value	95% CI
Median 8-OHdG Levels in the Conventional Period	323	222 – 471
Median 8-OHdG Levels in the Organic Period	296	202 – 447

Effect of Organic Treatment in 8-OHdG Levels in Urine, Taking in Account the Repeated Measures and Duration of Organic Period Secondary · 1 baseline sample, 2 samples in the conventional period (typical conventional diet) and 3 samples in the organic period, up to 40 days for each Period

A linear mixed-effect regression model was fitted for 8-OHdG (log-transformed, creatinine-adjusted). The model accounted for the duration and the effect of treatment. It included student-level (repeated measures within person) and school-level (multiple students clustered within each school) random intercepts with an unstructured covariance matrix. Continuous variables, other than time (days of treatment), were centered at the population means. The model included fixed effects for treatment condition (organic or conventional) and time (days of treatment), where time = 0 was used for the start

Group	Value	95% CI
Linear Mixed-effect Model of Log-transformed Oxidative Stress/Inflammation Biomarker 8-OHdG	-0.119	-0.213 – -0.024

Change in Oxidative Stress/Inflammation Biomarker 8-iso-PGF2a Levels in Urine Between Organic and Conventional Periods* Secondary · Last sample of the conventional period and the last sample of organic period, up to 40 days for each period

Percent change in oxidative stress/inflammation biomarker 8-iso-PGF2a levels between the last sample of the conventional treatment period (before the start of the organic treatment) and the last sample of organic treatment period. A one-sample t-test was used to assess whether the percent change was different than zero. \*Note: This test does not take into account the repeated measures for each participant and the organic treatment duration. The results of the linear-mixed effect models are the ones considered (reported in a section below) as they take into account the repeated measures for e

Group	Value	95% CI
% Change in 8-iso-PGF2a Between Last Sample of Conventional Period and Last Sample of Organic Period	1.6	0.2 – 2.9

Overall Difference in Median 8-iso-PGF2a Levels in Urine Between the Conventional and Organic Periods* Secondary · 1 baseline sample, 2 samples in the conventional period (typical conventional diet) and 3 samples in the organic period, up to 40 days for each Period

Overall difference in median 8-iso-PGF2a levels between the conventional and organic periods. The overall differences in the medians of biomarkers between the conventional and the organic phase were assessed with the non-parametric Wilcoxon rank sum test on the creatinine-adjusted concentrations pooling all conventional samples (including the baseline) and the organic samples for all participants, regardless of the duration for which they followed the organic treatment. \*Note: This test does not take into account the repeated measures for each participant and the organic treatment duration.

Group	Value	95% CI
Median 8-iso-PGF2a Levels in the Conventional Period	2964	2112 – 3871
Median 8-iso-PGF2a Levels in the Organic Period	3028	2300 – 3955

Effect of Organic Treatment in 8-iso-PGF2a Levels in Urine, Taking in Account the Repeated Measures and Duration of Organic Period Secondary · 1 baseline sample, 2 samples in the conventional period (typical conventional diet) and 3 samples in the organic period, up to 40 days for each Period

A linear mixed-effect regression model was fitted for 8-iso-PGF2a (log-transformed, creatinine-adjusted). The model accounted for the duration and the effect of treatment. It included student-level (repeated measures within person) and school-level (multiple students clustered within each school) random intercepts with an unstructured covariance matrix. Continuous variables, other than time (days of treatment), were centered at the population means. The model included fixed effects for treatment condition (organic or conventional) and time (days of treatment), where time = 0 was used for the s

Group	Value	95% CI
Linear Mixed-effect Model of Log-transformed Oxidative Stress/Inflammation Biomarker 8-iso-PGF2a	0.408	0.232 – 0.584

Change in Oxidative Stress/Inflammation Biomarker MDA Levels in Urine Between Organic and Conventional Periods* Secondary · Last sample of the conventional period and the last sample of organic period, up to 40 days for each period

Percent change in oxidative stress/inflammation biomarker MDA levels between the last sample of the conventional treatment period (before the start of the organic treatment) and the last sample of organic treatment period. A one-sample t-test was used to assess whether the percent change was different than zero. \*Note: This test does not take into account the repeated measures for each participant and the organic treatment duration. The results of the linear-mixed effect models are the ones considered (reported in a section below) as they take into account the repeated measures for each part

Group	Value	95% CI
% Change in MDA Between Last Sample of Conventional Period and Last Sample of Organic Period	0.1	-1.1 – 1.2

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A cluster-randomized crossover trial of organic diet impact on biomarkers of exposure to pesticides and biomarkers of oxidative stress/inflammation in primary school children.
   Makris KC, Konstantinou C, Andrianou XD, Charisiadis P, et al · · 2019 · cited 30× · PMID 31483785 · DOI 10.1371/journal.pone.0219420
2. Use of metabolomics in refining the effect of an organic food intervention on biomarkers of exposure to pesticides and biomarkers of oxidative damage in primary school children in Cyprus: A cluster-randomized cross-over trial.
   Konstantinou C, Gaengler S, Oikonomou S, Delplancke T, et al · · 2022 · cited 6× · PMID 34991267 · DOI 10.1016/j.envint.2021.107008