Organic Diet Intervention in Primary School Children (ORGANIKO)

• ClinicalTrials.gov Identifier: NCT02998203
• Recruitment Status: Completed
• First Posted: December 20, 2016
• Last Update Posted: April 19, 2017
• Sponsor: Cyprus University of Technology
• Collaborator: European Commission
• Information provided by (Responsible Party): Konstantinos Makris, Cyprus University of Technology

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Oxidative Stress; Inflammation	Dietary Supplement: Organic diet	Not Applicable

Detailed Description:

A single-blinded, randomised 2 x 2 cross-over study is conducted to evaluate the effect of a 40-day organic diet compared to a 40-day conventional diet on biomarkers of exposure (pesticides metabolites) and biomarkers of effect (oxidative stress/inflammation markers) in children. The study is approved by the Cyprus National Bioethics Committee (ΕΕΒΚ/ΕΠ/2016/25) and the Cyprus Ministry of Education and Culture (7.15.06.15/2). Written informed consent for children to participate in the study is obtained from children's parents or legal guardians. Study participants are recruited from public primary schools in Limassol, Cyprus following communication with the school's headmaster. Each school that participates in the study is randomized to one of the two study arms; conventional-organic or organic-conventional. Participants' blinding is not possible since children know which diet they have at each phase. However, all documents and urine containers are coded, so that researchers are blinded to subjects' identity and group allocation.

Participants provide 6 first morning urine samples during the duration of the study; 1 baseline sample, 2 samples in the conventional phase and 3 samples in the organic phase. Anthropometric measurements (weight, height, waist circumference) are taken at the beginning and end of the study by trained researchers at the school area. A baseline questionnaire is administered to parents at the beginning of the study through a telephone interview to collect information on demographic characteristics, pesticide use at household and children's activities. A food frequency questionnaire is administered to parents at the end of the conventional phase through a telephone interview to collect information about the food habits of the children during the 40-day conventional period. A food diary is given to parents at the beginning of the study and parents use it during the organic phase, to collect information about the compliance of the children to the organic dietary menu, the children's health status and the pesticide use at home.

In order to encourage adherence to the organic diet menu, an event is organised during the organic phase of both groups, with activities for children and free sampling of organic food products.

Descriptive statistics are used to summarize the demographic characteristics for participating children. Categorical variables are described as sample size and percentages, normally-distributed continuous variables as mean±SD and non-normal continuous variables as median and interquartile range (Q1-Q3) or the appropriate transformation is conducted, such as the log transformation. For testing whether characteristics of interest are different among groups the Student's t-test are utilized for continuous normally distributed variables and the chi-square test for categorical characteristics. For continuous data that are not normally distributed, the Wilcoxon non-parametric analysis is used instead or a transformation of the data is conducted first in order to meet the normality criterion.

Linear mixed-effects models are used to account for the correlation among repeat urine samples collected from the same child and determine whether mean pesticide metabolite and biomarkers concentrations differ between the organic phase and the conventional phase.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Investigator)
• Primary Purpose: Other
• Official Title: Organic Diet and Children's Health - ORGANIKO LIFE+
• Actual Study Start Date: January 3, 2017
• Actual Primary Completion Date: April 18, 2017
• Actual Study Completion Date: April 18, 2017

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Conventional phase; During the conventional phase, participants are asked to maintain their usual dietary choices for 40 days.
Experimental: Organic phase; 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; 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.

Outcome Measures

Primary Outcome Measures :

1. Change in pesticides metabolites (3-phenoxybenzoic acid (3-PBA) & 6-chloronicotinic acid (6 CNA)) in urine between: 1. baseline and after 40 days of organic diet 2. median of conventional phase and median of organic phase [ Time Frame: 1 Baseline sample, 2 samples in the Conventional Phase (20 days and 40 days after consuming their typical conventional diet) and 3 samples in the Organic Phase (15 days, 30 days and 40 days after the introduction of organic diet) ]
   Units of measure: μg/L

Secondary Outcome Measures :

1. Change in biomarkers of oxidative stress/inflammation (IL-6, isoprostanes, malondialdehyde) in urine between: 1. baseline and after 40 days of organic diet 2. conventional phase and organic phase [ Time Frame: 1 Baseline sample, 2 samples in the Conventional Phase (20 days and 40 days after consuming their typical conventional diet) and 3 samples in the Organic Phase (15 days, 30 days and 40 days after the introduction of organic diet) ]
   Units of measure: μg/L

Eligibility Criteria

• Ages Eligible for Study: 10 Years to 12 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Sponsors and Collaborators

Cyprus University of Technology

European Commission

Investigators

• Study Director: Konstantinos C Makris; Cyprus University of Technology

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Konstantinos Makris, Associate Professor of Environmental Health, Cyprus University of Technology
• ClinicalTrials.gov Identifier: NCT02998203
• Other Study ID Numbers: CyprusUT
• First Posted: December 20, 2016
• Last Update Posted: April 19, 2017
• Last Verified: April 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by Konstantinos Makris, Cyprus University of Technology:

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

Additional relevant MeSH terms:

Inflammation; Pathologic Processes