Effect of Breastfeeding on Lipid Profile and Cardiovascular Risk Markers in Women With Familial Hypercholesterolemia

NCT05367310 | Active Not Recruiting

• 1 other identifier: 395816
• Study Type: observational
• Target: 50
• Locations: 3 countries
• Sites: 4

Brief Summary

The study aims to investigate the effects of breastfeeding on lipid profile and cardiovascular risk markers in women with familial hypercholesterolemia (FH) compared to women without FH. Women with FH will be recruited in Norway, the Netherlands, and the Czech Republic. Women without FH will be recruited in Norway. Women with and without FH who are pregnant or planning pregnancy will be recruited, and will be invited to repeated study visits from the end of pregnancy and through the first year after delivery. Blood samples and data on anthropometry, health, pregnancy, lifestyle and diet will be collected. Statin transfer into breast milk will also be measured in breast milk samples collected when the women end breastfeeding the child and start statin treatment.

Conditions

Familial Hypercholesterolemia

Keywords

Breastfeeding; Cardiovascular disease; Pregnancy; Lipid profile; Women

Outcome Measures

Primary Outcomes (1)

• Change in serum lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides, lipoprotein(a)) from 2-4 weeks postpartum up to 12 months postpartum (absolute and relative change).

  Investigate the change in lipid profile (total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides) in women with and without familial hypercholesterolemia, by blood sampling at repeated time points during breastfeeding period.

  Up to 12 months after delivery or end of breastfeeding period

Secondary Outcomes (6)

• Association between breastfeeding (yes/no, exclusive/partial, frequency, and duration) and inflammatory markers (e.g. C-reactive protein (CRP).

  Up to 12 months after delivery or end of breastfeeding period

• Association between breastfeeding (yes/no, exclusive/partial, frequency, and duration) and metabolic markers (e.g. glucose).

  Up to 12 months after delivery or end of breastfeeding period

• Association between breastfeeding (yes/no, exclusive/partial, frequency, and duration) and maternal weight.

  Up to 12 months after delivery or end of breastfeeding period

• Investigate the breast milk composition (lipids and metabolites) throughout the breastfeeding period.

  Up to 12 months after delivery or end of breastfeeding period

• Investigate the concentration of statins in the breast milk and dried blood spot of the offspring of women with FH after start of lipid-lowering medication.

  Repeated milk sampling up to one week after start of ordinary statin treatment.

Study Arms (2)

Women with familial hypercholesterolemia

Women with familial hypercholesterolemia

Women without hypercholesterolemia

Women without hypercholesterolemia

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with and without familial hypercholesterolemia (FH)

You may qualify if:

• age 18 years or older,
• confirmed diagnosis of FH through genetic testing or clinical assessment based on the Dutch Lipid Clinic Network,
• singleton pregnancy in the third trimester,
• a sufficient command of Norwegian, Dutch, Czech or English language.

You may not qualify if:

• age 18 years or older,
• singleton pregnancy in the third trimester,
• a sufficient command of Norwegian or English language.
• known pre-pregnancy hypercholesterolemia,
• a history of ASCVD.

Sponsors & Collaborators

• University of Oslo: collaborator
• Oslo University Hospital: lead

Study Sites (4)

Centre of Cardiovascular Surgery and Transplantation

Brno, Czechia

Location

Third Department of Internal Medicine, General University Hospital, First Faculty of Medicine, Charles University

Prague, Czechia

Location

Department of Internal Medicine, Erasmus MC Cardiovascular Institute

Rotterdam, Netherlands

Location

Oslo University Hospital

Oslo, Norway

Location

Related Publications (2)

• Klevmoen M, van Lennep JR, Bogsrud MP, Vesterbekkmo EK, Pedersen EKR, Hovland A, Mulder JWCM, Brekke HK, Iversen PO, Vaclova M, Vrablik M, Freiberger T, Retterstol K, Holven KB. Extensive pregnancy-related off-treatment time in women with familial hypercholesterolaemia. Atherosclerosis. 2026 Feb 19;415:120668. doi: 10.1016/j.atherosclerosis.2026.120668. Online ahead of print.

  PMID: 41740525 DERIVED

• Klevmoen M, Mulder JWCM, Bogsrud MP, Retterstol K, Vesterbekkmo EK, Pedersen EKR, Freiberger T, Vrablik M, Vaclova M, Hovland A, Vethe NT, Brekke HK, Iversen PO, Veierod M, Roeters van Lennep J, Holven KB. Prospective study on breastfeeding, lipid profile and cardiovascular risk markers in women with familial hypercholesterolaemia: study protocol for the FH-FEMINA study. BMJ Open. 2025 Apr 27;15(4):e092208. doi: 10.1136/bmjopen-2024-092208.

  PMID: 40288796 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, plasma, peripheral blood mononuclear cells, breastmilk

MeSH Terms

Conditions

Hyperlipoproteinemia Type II; Breast Feeding; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Feeding Behavior; Behavior

Study Officials

• Kirsten Holven, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 30, 2022
• First Posted: May 10, 2022
• Study Start: May 1, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

NO (1); NL (1); CZ (2)