Cardiovascular Risk Reduction-Diet in Pregnancy - Follow up 20 Years After the "CARRDIP"-Trial (CARRDIP20)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Nutrition
• Intervention / Treatment: Other: Antiatherogenic diet

• Study Type: Interventional
• Enrollment (Estimated): 538
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo
    • Oslo, Oslo, Norway, 0254
      • University of Oslo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diet intervention; Follow up of both mother and offspring 20 years after allocation to an antiatherogenic diet during pregnancy.	Other: Antiatherogenic diet; Participants instructed in antiatherogenic diet during pregnancy with frequent follow-ups to ensure compliance
No Intervention: Control; Follow up of both mother and offspring 20 years after allocation to control group during pregnancy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood samples - Lipid profile	Ratio of non-HDL cholesterol to HDL cholesterol in blood	1 day
Blood samples - Lipid profile	Lipoprotein a concentration in blood	1 day
Anthropometry	Waist-to-hip ratio (WHR)	1 day
Body fat percentage	Measured by bioimpedance	1 day
Ultrasound examination of liver	Ultrasound-Guided Attenuation Parameter (UGAP) of liver	1 day
Ultrasound examination of carotid artery	Intima-media thickness in carotid artery	1 day
Blood samples - Glukose metabolism	Hemoglobin A1c concentration in blood as a measure of long term blood sugar levels	1 day
Mean arterial pressure (MAP)	Measured by	1 day

Collaborators and Investigators

• Sponsor: Per Ole Iversen, MD
• Collaborators: Oslo University Hospital

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Helpful Links

• Link to project homepage on University of Oslo domain (norwegian)

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: August 20, 2021
• First Submitted That Met QC Criteria: August 26, 2021
• First Posted (Actual): September 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 20/00301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no current plan to share individual patient data due to limitations in ethical approval and data protection considerations of the project.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No