Organic Diet Intervention in Primary School Children (ORGANIKO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02998203|
Recruitment Status : Completed
First Posted : December 20, 2016
Last Update Posted : April 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Oxidative Stress Inflammation||Dietary Supplement: Organic diet||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Crossover Assignment|
|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|
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.
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02998203
|Study Director:||Konstantinos C Makris||Cyprus University of Technology|