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

Per Ole Iversen, MD

Status: Enrolling

Conditions: Nutrition

Treatments: Other: Conventional diet; Other: Organic diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05269225

304336

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups, including a placebo group

Organic diet

Experimental group

Description:

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

Treatment:

Other: Organic diet

Conventional diet

Placebo Comparator group

Description:

Consuming conventional food throughout the whole pregnancy.

Treatment:

Other: Conventional diet