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

NCT05269225 | Active Not Recruiting DMC

• 1 other identifier: 304336
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Blood concentration of cholesterol

  2.5 years

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

  2.5 years

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

  2.5 years

• Child body weight

  2 years

• Child urinary excretion level of dialkylphosphates

  2 years

Study Arms (2)

Organic diet

EXPERIMENTAL

Consuming organic food from the start of 2nd trimester and until gestational week 37.

Other: Organic diet

Conventional diet

PLACEBO COMPARATOR

Consuming conventional food throughout the whole pregnancy.

Other: Conventional diet

Interventions

Organic diet OTHER

Organically produced foods.

Organic diet

Conventional diet OTHER

Conventionally produced foods.

Also known as: Control

Conventional diet

Eligibility Criteria

• Gender Eligibility Details: Only pregnant women will be included
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Nulli- or multipara pregnant in first trimester

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: collaborator
• Per Ole Iversen, MD: lead

Study Sites (1)

University of Oslo

Oslo, 0317, Norway

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: March 7, 2022
• Study Start: May 2, 2022
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)