Organic Diet in Pregnancy and Risk Markers of Health Effects (The OrgDiet Project)

Study Overview
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Brief Summary
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The OrgDiet project is a two-armed (1:1), open, intention-to-treat randomized controlled trial. The aim is to examine effects of consumption of organic foods (intervention group) vs. conventional foods (control group) during pregnancy in both mother and child. About 100 participants will be included and the participants will be followed until the children are two years old. Both groups will also be recommended to eat according to the dietary guidelines of the Directory of Health in Norway.

Official Title
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Organic Diet in Pregnancy and Risk Markers of Health Effects

Conditions
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Nutrition

Intervention / Treatment
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* Other: Organic diet
* Other: Conventional diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Nulli- or multipara pregnant in first trimester Exclusion Criteria: Consuming an organic diet regularly Using medication regularly that might interfere with study adherence or - outcomes Diagnosed with a chronic disorder or cancer Having a food allergy or intolerance
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Organic diet<br>Consuming organic food from the start of 2nd trimester and until gestational week 37. | Other: Organic diet<br>* Organically produced foods.<br>|
| Placebo Comparator: Conventional diet<br>Consuming conventional food throughout the whole pregnancy. | Other: Conventional diet<br>* Conventionally produced foods.<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal urinary excretion level of dialkylphosphates | The difference in maternal urinary excretion level of these pesticides at the end of intervention (gestational week 37) between the intervention group and the control group, measured at baseline (gestational week 12-14), and at several occasions until 2 years after the birth of the baby. | 2.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood concentration of cholesterol | The difference in blood concentration of cholesterol at the end of intervention (gestational week 37) between the intervention group and the control group, measured at baseline (gestational week 12-14), and at several occasions until 2 years after the birth of the baby. | 2.5 years | 
| Abundance and species-types of gut microbiota (e.g. staphylococci and enterobacter) sampled from stool samples | The difference in microbiota species-types and abundance (using 16S rRNA amplicon sequencing) in stool samples between the intervention group and the control group, measured at baseline (gestational week 12-14), and at several occasions until 2 years after the birth of the baby. | 2.5 years | 
| DNA methylation patterns in leucocytes as a marker of altered epigenetic programming | DNA methylation will be investigated on DNA isolated from leukocytes. Degree of DNA methylation will be analyzed at a genome-wide scale using Illumina Infinium EPIC bead chip array (or similar methods, depending on the cost-benefit consideration at the time). The DNA methylation data will be normalized, and presented as beta-values ranging from 0-1. The outcome measure in the study is intra-individual DNA methylation changes during the study-period, measured as changes in the beta-value, between the intervention group and the control group, measured at baseline (gestational week 12-14), and at several occasions until 2 years after the birth of the baby. | 2.5 years | 
| Child body weight | The difference in child body weight (kg) between the intervention group and the control group, measured at baseline (birth), and at several occasions until 2 years after the birth of the baby. | 2 years | 
| Child urinary excretion level of dialkylphosphates | The difference in child urinary excretion level of dialkylphosphates between the intervention group and the control group, measured at several occasions until 2 years after the birth of the baby. | 2 years | 
| Blood concentration HbA1c | The difference in blood concentration of HbA1c at the end of intervention (gestational week 37) between the intervention group and the control group, measured at baseline (gestational week 12-14), and at several occasions until 2 years after the birth of the baby. | 2.5 years | 
| Blood concentration CRP | The difference in blood concentration of CRP at the end of intervention (gestational week 37) between the intervention group and the control group, measured at baseline (gestational week 12-14), and at several occasions until 2 years after the birth of the baby. | 2.5 years | 
| Child body length | The difference in child body length (cm) between the intervention group and the control group, measured at baseline (birth), and at several occasions until 2 years after the birth of the baby. | 2 years |