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NCT05030922 Clinical Trial

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

Nutrition Clinical Trial

— CARRDIP20  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05030922
Other study ID # 20/00301
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2021
Est. completion date June 1, 2024

Study information
Verified date May 2023
Source University of Oslo
Contact Per Ole Iversen, MD
Phone +47 22851391
Email p.o.iversen@medisin.uio.no
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 538
Est. completion date June 1, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Antiatherogenic diet
Participants instructed in antiatherogenic diet during pregnancy with frequent follow-ups to ensure compliance

Locations
Country Name City State
Norway University of Oslo Oslo

Sponsors (2)
Lead Sponsor Collaborator
Per Ole Iversen, MD Oslo University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

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