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NCT Number: NCT05030922

Cardiovascular Risk Reduction-Diet in Pregnancy - Follow up 20 Years After the "CARRDIP"-Trial

The "Cardiovascular Risk Reduction-Diet in Pregnancy" (CARRDIP) - is a randomised controlled trial with dietary intervention during pregnancy. The participants were enrolled in Norway 20 years ago and consisted of 269 pregnant, healthy mothers. The participants were randomised 1:1 to either intervention-diet or control. The intervention diet was build upon an anti-atherogenic principle and was a so called "Mediterranean diet". The participants were monitored during pregnancy, and mother and child participated in a follow-up study 1 year after birth. The current "CARRDIP20" trial is a follow-up of the same participants, both mother and offspring, 20 years after the original intervention to measure and analyse the cardiovascular health and compare the intervention group to the control group.

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Key information

Conditions

Nutrition

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oslo

Oslo, 0254, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

from original CARRDIP-trial:

  • Non-smoking pregnant women
  • BMI 19 to 32 kg/m2 at inclusion
  • Age 21 to 38 years
  • Carrying a single foetus

Exclusion criteria

  • Previous pregnancy complications

Treatment and study plan

Antiatherogenic diet

Other

Participants instructed in antiatherogenic diet during pregnancy with frequent follow-ups to ensure compliance

Primary outcomes

  1. Cardiovascular health score

    Time frame: 1 day

    Cardiovascular risk score by use of the most appropriate available risk score algorithm available at time of analysis, at present the preferred calculator is Life's Simple 7 - The American Heart Association https://doi.org/10.1161/CIRCULATIONAHA.109.192703

Secondary outcomes

  1. Blood samples - Lipid profile

    Time frame: 1 day

    Ratio of non-HDL cholesterol to HDL cholesterol in blood

  2. Blood samples - Lipid profile

    Time frame: 1 day

    Lipoprotein a concentration in blood

  3. Anthropometry

    Time frame: 1 day

    Waist-to-hip ratio (WHR)

  4. Body fat percentage

    Time frame: 1 day

    Measured by bioimpedance

  5. Ultrasound examination of liver

    Time frame: 1 day

    Ultrasound-Guided Attenuation Parameter (UGAP) of liver

  6. Ultrasound examination of carotid artery

    Time frame: 1 day

    Intima-media thickness in carotid artery

  7. Blood samples - Glukose metabolism

    Time frame: 1 day

    Hemoglobin A1c concentration in blood as a measure of long term blood sugar levels

  8. Mean arterial pressure (MAP)

    Time frame: 1 day

    Measured by

Sponsors and collaborators

Lead sponsor

Per Ole Iversen, MD

Other

Collaborators

  • Oslo University Hospital

Registry information

Acronym: CARRDIP20

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Sep 1, 2021
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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