NutritionCARRDIP20NCT05030922
Cardiovascular Risk Reduction-Diet in Pregnancy - Follow up 20 Years After the "CARRDIP"-Trial
A study testing Antiatherogenic diet in people with Nutrition, run by Per Ole Iversen, MD at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nutrition
- What is being tested?
- Antiatherogenic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 538 participants
- Where
- 1 siteNorway
- Study dates
- 1 Dec 2021to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Non-smoking pregnant women
- BMI 19 to 32 kg/m2 at inclusion
- Age 21 to 38 years
- Carrying a single foetus
Who cannot join
- Previous pregnancy complications
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Nutrition
- Being tested
- Antiatherogenic diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiatherogenic dietOther
Participants instructed in antiatherogenic diet during pregnancy with frequent follow-ups to ensure compliance
| Study group | Role | What they receive |
|---|---|---|
| Diet intervention | Experimental | Follow up of both mother and offspring 20 years after allocation to an antiatherogenic diet during pregnancy. Receives: Other: Antiatherogenic diet |
| Control | No intervention | Follow up of both mother and offspring 20 years after allocation to control group during pregnancy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (8)
Blood samples - Lipid profile
Ratio of non-HDL cholesterol to HDL cholesterol in blood
Measured: 1 day
Blood samples - Lipid profile
Lipoprotein a concentration in blood
Measured: 1 day
Anthropometry
Waist-to-hip ratio (WHR)
Measured: 1 day
Body fat percentage
Measured by bioimpedance
Measured: 1 day
Ultrasound examination of liver
Ultrasound-Guided Attenuation Parameter (UGAP) of liver
Measured: 1 day
Ultrasound examination of carotid artery
Intima-media thickness in carotid artery
Measured: 1 day
Blood samples - Glukose metabolism
Hemoglobin A1c concentration in blood as a measure of long term blood sugar levels
Measured: 1 day
Mean arterial pressure (MAP)
Measured by
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start1 Dec 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 538 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Per Ole Iversen, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital
- Responsible party
- Sponsor-investigator, Per Ole Iversen, MD, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030922
- Sponsor's protocol ID
- 20/00301
- Acronym
- CARRDIP20
- Status last verified
- Apr 2026
- First submitted
- 20 Aug 2021
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no current plan to share individual patient data due to limitations in ethical approval and data protection considerations of the project.
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 17547890Khoury 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 16202717Khoury 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 17217362Troensegaard H, Veierod MB, Westerberg AC, Carlsen MH, Tonstad S, Bjornerem A, Holven KB, Retterstol K, Iversen PO, Khoury J. No Differences in Blood Pressure or Anthropometric Measures in 3-Year-Old Children After a Randomized Mediterranean Dietary Intervention During Pregnancy in Norway. Acta Paediatr. 2026 Aug 10. doi: 10.1111/apa.70721. Online ahead of print.
PubMed 42573466Troensegaard 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Risk Reduction-Diet in Pregnancy - Follow up 20 Years After the "CARRDIP"-Trial
- ClinicalTrials.gov ID
- NCT05030922
- Acronym / sponsor ID
- CARRDIP20 / 20/00301
- Conditions
- Nutrition
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 538 participants (estimated)
- Lead sponsor
- Per Ole Iversen, MDUniversity, hospital or other
- Collaborators
- Oslo University Hospital
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet intervention | Experimental | Other: Antiatherogenic dietFollow up of both mother and offspring 20 years after allocation to an antiatherogenic diet during pregnancy. |
| Control | No intervention | –Follow up of both mother and offspring 20 years after allocation to control group during pregnancy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Non-smoking pregnant women
- BMI 19 to 32 kg/m2 at inclusion
- Age 21 to 38 years
- Carrying a single foetus
Key exclusion criteria (1 listed)
- Previous pregnancy complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antiatherogenic dietParticipants instructed in antiatherogenic diet during pregnancy with frequent follow-ups to ensure compliance | Other | Diet intervention |
Primary outcome
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
8 secondary outcomes
Blood samples - Lipid profile
Time frame: 1 day
Blood samples - Lipid profile
Time frame: 1 day
Anthropometry
Time frame: 1 day
Body fat percentage
Time frame: 1 day
Ultrasound examination of liver
Time frame: 1 day
Ultrasound examination of carotid artery
Time frame: 1 day
Blood samples - Glukose metabolism
Time frame: 1 day
Mean arterial pressure (MAP)
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Background: PubMed 17547890Khoury 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.
- Background: PubMed 16202717Khoury 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.
- Background: PubMed 17217362Khoury 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.
- Derived from this study: PubMed 42573466Troensegaard H, Veierod MB, Westerberg AC, Carlsen MH, Tonstad S, Bjornerem A, Holven KB, Retterstol K, Iversen PO, Khoury J. No Differences in Blood Pressure or Anthropometric Measures in 3-Year-Old Children After a Randomized Mediterranean Dietary Intervention During Pregnancy in Norway. Acta Paediatr. 2026 Aug 10. doi: 10.1111/apa.70721. Online ahead of print.
- Derived from this study: PubMed 37920793Troensegaard 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.
- Link to project homepage on University of Oslo domain (norwegian)Link provided by the sponsor.
- Individual participant dataSharing planned: No. There is no current plan to share individual patient data due to limitations in ethical approval and data protection considerations of the project.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antiatherogenic diet in people with Nutrition, run by Per Ole Iversen, MD at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular health score (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05030922, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.