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

Nutrition Clinical Trial

Official title:

Organic Diet in Pregnancy and Risk Markers of Health Effects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05269225
• Other study ID #: 304336
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2023
• Source: University of Oslo
• Contact: Per Ole Iversen, MD
• Phone: +47 22851391
• Email: p.o.iversen[@]medisin.uio.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Nutrition

Intervention

Other:
• Organic diet
Organically produced foods.
• Conventional diet
Conventionally produced foods.

Locations

Country	Name	City	State
Norway	University of Oslo	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Per Ole Iversen, MD	Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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