Organic Diet Intervention in Primary School Children

NCT02998203 | Completed Results DMC

• 1 other identifier: CyprusUT
• Study Type: interventional
• Target: 191
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Oxidative Stress; Inflammation

Keywords

organic diet; health; pesticides; inflammation biomarkers; oxidative stress biomarkers

Outcome Measures

Primary Outcomes (5)

• Change in Pesticide Metabolite 3-phenoxybenzoic Acid (3-PBA) Levels in Urine Between Organic and Conventional Periods*

  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 each participant and the organic treatment duration.

  Last sample of the conventional period and the last sample of organic period, up to 40 days for each period

• Overall Difference in Median 3-PBA Levels in Urine Between the Conventional and Organic Periods*

  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 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 participant and the organic treatment duration.

  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

• Effect of Organic Treatment in 3-PBA Levels in Urine, Taking in Account the Repeated Measures and Duration of Organic 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 of the treatment. The model was adjusted for the baseline value (first urine sample for all children) of the outcome to account for the background participant levels. An interaction term for time and treatment was considered and subsequently dropped if it did not meet the threshold of p-value\<0. 05.

  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-chloronicotininc Acid (6-CN) Levels in Urine Between the Conventional and Organic Periods*

  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 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 participant and the organic treatment duration.

  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

• 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

  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 used for the start of the treatment. The model was adjusted for the baseline value (first urine sample for all children) of the outcome to account for the background participant levels. An interaction term for time and treatment was considered and subsequently dropped if it did not meet the threshold of p-value\<0. 05.

  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

Secondary Outcomes (9)

• Change in Oxidative Stress/Inflammation Biomarker 8-OHdG Levels in Urine Between Organic and Conventional Periods*

  Last sample of the conventional period and the last sample of organic period, up to 40 days for each period

• Overall Difference in Median 8-OHdG Levels in Urine Between the Conventional and Organic Periods*

  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

• Effect of Organic Treatment in 8-OHdG Levels in Urine, Taking in Account the Repeated Measures and Duration of Organic Period

  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

• Change in Oxidative Stress/Inflammation Biomarker 8-iso-PGF2a Levels in Urine Between Organic and Conventional Periods*

  Last sample of the conventional period and the last sample of organic period, up to 40 days for each period

• Overall Difference in Median 8-iso-PGF2a Levels in Urine Between the Conventional and Organic Periods*

  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

Study Arms (2)

Conventional phase

NO INTERVENTION

During the conventional phase, participants are asked to maintain their usual dietary choices for 40 days.

Organic phase

EXPERIMENTAL

During the organic phase, participants are asked to follow strictly the two 20-day organic dietary menus provided to them for 40 days. The organic dietary menus were prepared by a certified dietitian. The meals of the organic phase are prepared by a certified organic restaurant and are delivered to school every day except Sunday. For the meals of breakfast and afternoon snacks, children choose their preferred options for the week on the Friday of the previous week according to a list of organic food items and the products for these meals are delivered on Saturday along with the rest meals. Parents are responsible to pick-up the organic meals from school and ensure that the participating children have access to them.

Dietary Supplement: Organic diet

Interventions

Organic diet DIETARY_SUPPLEMENT

Full organic diet from certified organic products as obtained from certified producers and cooked by a certified organic restaurant. five meals each day delivered to students.

Organic phase

Eligibility Criteria

• Age: 10 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cyprus University of Technology: lead
• European Commission: collaborator

Related Publications (2)

• Makris KC, Konstantinou C, Andrianou XD, Charisiadis P, Kyriacou A, Gribble MO, Christophi CA. 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. PLoS One. 2019 Sep 4;14(9):e0219420. doi: 10.1371/journal.pone.0219420. eCollection 2019.

  PMID: 31483785 RESULT

• Konstantinou C, Gaengler S, Oikonomou S, Delplancke T, Charisiadis P, Makris KC. 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. Environ Int. 2022 Jan;158:107008. doi: 10.1016/j.envint.2021.107008. Epub 2021 Nov 30.

  PMID: 34991267 DERIVED

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The reported compliance may not reflect the actual compliance of the children to the organic diet, as children could either not consume all meal portion, or families could provide them with extra organic food items.

Results Point of Contact

• Title: Dr. Konstantinos C. Makris
• Organization: Cyprus University of Technology

konstantinos.makris@cut.ac.cy

00357-25-002398

Study Officials

• Konstantinos C Makris

  Cyprus University of Technology

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Environmental Health

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 20, 2016
• Study Start: January 3, 2017
• Primary Completion: April 18, 2017
• Study Completion: April 18, 2017
• Last Updated: September 7, 2023
• Results First Posted: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Following the publication of the manuscript, all relevant info is made available to the public.
• Access Criteria: Following the publication of the manuscript, all relevant info is made available to the public.