CClinicalTrials.gg
Sign In
Active, not recruitingNCT05030922CARRDIP20Updated Apr 28, 2026

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

An interventional study of Antiatherogenic diet in Nutrition, sponsored by Per Ole Iversen, MD. Active, not recruiting at 1 site in Norway. Per ClinicalTrials.gov, last updated 2026-04-28.

Sponsored by Per Ole Iversen, MD · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
538
Allocation
Randomized
Sex
All
01

Study summary

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.

02

Conditions studied

  • Nutrition
03

In context

Lead sponsor

Per Ole Iversen, MD is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Previous pregnancy complications
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
538 participants (estimated)

Study arms

  • Experimental
    Diet intervention

    Follow up of both mother and offspring 20 years after allocation to an antiatherogenic diet during pregnancy.

    Other: Antiatherogenic diet

  • No intervention
    Control

    Follow up of both mother and offspring 20 years after allocation to control group during pregnancy.

Interventions

  • OtherAntiatherogenic diet

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

06

What researchers measure

Primary outcomes

  1. Cardiovascular health score

    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

    Time frame: 1 day

Secondary outcomes

  1. Blood samples - Lipid profile

    Ratio of non-HDL cholesterol to HDL cholesterol in blood

    Time frame: 1 day

  2. Blood samples - Lipid profile

    Lipoprotein a concentration in blood

    Time frame: 1 day

  3. Anthropometry

    Waist-to-hip ratio (WHR)

    Time frame: 1 day

  4. Body fat percentage

    Measured by bioimpedance

    Time frame: 1 day

  5. Ultrasound examination of liver

    Ultrasound-Guided Attenuation Parameter (UGAP) of liver

    Time frame: 1 day

  6. Ultrasound examination of carotid artery

    Intima-media thickness in carotid artery

    Time frame: 1 day

  7. Blood samples - Glukose metabolism

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

    Time frame: 1 day

  8. Mean arterial pressure (MAP)

    Measured by

    Time frame: 1 day

07

Study locations

1 site
  • University of Oslo
    Oslo, Oslo 0254, Norway
08

References and documents

Publications

  • Khoury J, Haugen G, Tonstad S, Froslie KF, Henriksen T. Effect of a cholesterol-lowering diet during pregnancy on maternal and fetal Doppler velocimetry: the CARRDIP study. Am J Obstet Gynecol. 2007 Jun;196(6):549.e1-7. doi: 10.1016/j.ajog.2007.01.017. PubMed 17547890 ↗
  • Khoury J, Henriksen T, Christophersen B, Tonstad S. Effect of a cholesterol-lowering diet on maternal, cord, and neonatal lipids, and pregnancy outcome: a randomized clinical trial. Am J Obstet Gynecol. 2005 Oct;193(4):1292-301. doi: 10.1016/j.ajog.2005.05.016. PubMed 16202717 ↗
  • Khoury J, Henriksen T, Seljeflot I, Morkrid L, Froslie KF, Tonstad S. Effects of an antiatherogenic diet during pregnancy on markers of maternal and fetal endothelial activation and inflammation: the CARRDIP study. BJOG. 2007 Mar;114(3):279-88. doi: 10.1111/j.1471-0528.2006.01187.x. PubMed 17217362 ↗
  • Troensegaard H, Khoury J, Westerberg AC, Tonstad S, Roeters van Lennep J, Veierod MB, Iversen PO, Holven KB, Retterstol K. Protocol for a 20-year follow-up after a randomized controlled trial of a Mediterranean diet in pregnancy: maternal and offspring risk factors for cardiovascular disease. Front Pediatr. 2023 Oct 18;11:1256815. doi: 10.3389/fped.2023.1256815. eCollection 2023. PubMed 37920793 ↗

Individual participant data

Plan to share: No — There is no current plan to share individual patient data due to limitations in ethical approval and data protection considerations of the project.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05030922
Lead sponsor
Per Ole Iversen, MD
Collaborators
Oslo University Hospital
Responsible party
Per Ole Iversen, MD (Professor, University of Oslo) — Sponsor-investigator
First posted
Sep 1, 2021
Start date
Dec 1, 2021
Primary completion
Dec 31, 2026 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Apr 28, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Per Ole Iversen, MD

Start the discussion