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

Organic Diet in Pregnancy and Risk Markers of Health Effects

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Nutrition
• Intervention / Treatment: Other: Organic diet; Other: Conventional diet

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0317
    • University of Oslo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Per Ole Iversen, MD
• Collaborators: Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2022
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 1, 2022
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (Actual): March 7, 2022

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 304336

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no current plan to share individual patient data due to limitations in ethical approval and data protection considerations of the project.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No