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

NCT ID: NCT05269225

Last Updated: 2025-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-02

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Organic diet

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

Group Type EXPERIMENTAL

Organic diet

Intervention Type OTHER

Organically produced foods.

Conventional diet

Consuming conventional food throughout the whole pregnancy.

Group Type PLACEBO_COMPARATOR

Conventional diet

Intervention Type OTHER

Conventionally produced foods.

Interventions

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Organic diet

Organically produced foods.

Intervention Type OTHER

Conventional diet

Conventionally produced foods.

Intervention Type OTHER

Other Intervention Names

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Control

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role collaborator

Per Ole Iversen, MD

OTHER

Sponsor Role lead

Responsible Party

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Per Ole Iversen, MD

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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University of Oslo

Oslo, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Per Ole Iversen, MD

Role: CONTACT

+47 22851391

Kristin S Rosnes, RDN

Role: CONTACT

+47 90768181

Facility Contacts

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Per Ole Iversen, MD

Role: primary

+47 22851391

Kristin S Rosnes, RDN

Role: backup

+47 90768181

Other Identifiers

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304336

Identifier Type: -

Identifier Source: org_study_id

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