Nutrition
Conditions
Brief summary
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.
Interventions
OTHEROrganic diet
Organically produced foods.
OTHERConventional diet
Conventionally produced foods.
Sponsors
Oslo University Hospital
Per Ole Iversen, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal urinary excretion level of dialkylphosphates | 2.5 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abundance and species-types of gut microbiota (e.g. staphylococci and enterobacter) sampled from stool samples | 2.5 years | 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. |
| DNA methylation patterns in leucocytes as a marker of altered epigenetic programming | 2.5 years | 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. |
| Child body weight | 2 years | 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. |
| Blood concentration of cholesterol | 2.5 years | 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. |
| Blood concentration HbA1c | 2.5 years | 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. |
| Blood concentration CRP | 2.5 years | 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. |
| Child body length | 2 years | 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. |
| Child urinary excretion level of dialkylphosphates | 2 years | 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. |
Countries
Norway
Contacts
Primary ContactPer Ole Iversen, MD
Backup ContactKristin S Rosnes, RDN
Outcome results
None listed