An interventional study of Organic diet and Conventional diet in Nutrition, sponsored by Per Ole Iversen, MD. Active, not recruiting at 1 site in Norway. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by Per Ole Iversen, MD · Not applicable, Interventional, and Prevention
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.
Per Ole Iversen, MD is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Consuming organic food from the start of 2nd trimester and until gestational week 37.
Other: Organic diet
Consuming conventional food throughout the whole pregnancy.
Other: Conventional diet
Organically produced foods.
Conventionally produced foods.
Also known as: Control
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.
Time frame: 2.5 years
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2 years
Plan to share: No — There is no current plan to share individual patient data due to limitations in ethical approval and data protection considerations of the project.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Per Ole Iversen, MD