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NCT Number: NCT05269225

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

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.

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Key information

Conditions

Nutrition

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Oslo

Oslo, 0317, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Organic diet

Other

Organically produced foods.

Conventional diet

Other

Conventionally produced foods.

Other names: Control

Primary outcomes

  1. Maternal urinary excretion level of dialkylphosphates

    Time frame: 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 outcomes

  1. Blood concentration of cholesterol

    Time frame: 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.

  2. Abundance and species-types of gut microbiota (e.g. staphylococci and enterobacter) sampled from stool samples

    Time frame: 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.

  3. DNA methylation patterns in leucocytes as a marker of altered epigenetic programming

    Time frame: 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.

  4. Child body weight

    Time frame: 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.

  5. Child urinary excretion level of dialkylphosphates

    Time frame: 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.

  6. Blood concentration HbA1c

    Time frame: 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.

  7. Blood concentration CRP

    Time frame: 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.

  8. Child body length

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Per Ole Iversen, MD

Other

Collaborators

  • Oslo University Hospital

Registry information

Official study title

Organic Diet in Pregnancy and Risk Markers of Health Effects

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 7, 2022
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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