Effect of Omega-3 Fatty Acid on Endothelial Function

Effect of Omega-3 Polyunsaturated Fat on Endothelial Function and Inflammatory Parameters in Familial Hypercholesterolemia - a Double Blind, Placebo-controlled Crossover Study

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01813006

Enrollment

Registered

2013-03-18

Start date

2013-03-31

Completion date

2017-12-31

Last updated

2019-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Familial Hypercholesterolemia

Brief summary

Background Familial hypercholesterolemia (FH) is an inherited disease in which the level of bad cholesterol (LDL-cholesterol) is increased, leading to an increase in coronary heart disease even if adequately treated with cholesterol lowering medication (statins). Polyunsaturated fatty acids (PUFA) including omega-3 is known to affect the risk for coronary disease, however its effect on patients with FH is not known. The purpose of the study is to assess the effect of PUFA on patients with FH, with regard to inflammation measured in the blood and the effect on the blood vessels'ability to relax (endothelial function) by means of tonometry. Hypothesis Treatment with 4 grams of PUFA a day for 4 months will lead to an improvement in the endothelial function, and the treatment will also lead to a decrease in in several markers of inflammation and in lipids in the blood.

Interventions

DRUGOmega-3

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* documented familial hypercholesterolemia * age 18-60 years * on statin treatment for at least 12 months

Exclusion criteria

* pregnancy or planned pregnancy * breast feeding * cancer * non-compliance * PUFA/omega-3 \< 3 months before inclusion

Design outcomes

Primary

Measure	Time frame	Description
Reactive Hyperemia Index (RHI)	Baseline	Reactive Hyperemia Index (RHI) is a measure for endothelial function by means of tonometry

Secondary

Measure	Time frame	Description
Markers of inflammation	Baseline	Serological markers of inflammation including cytokines, C-reactive protein (CRP) and complement factors
Inflammatory markers	3 months	Serological markers of inflammation including cytokines, CRP and complement factors

Other

Measure	Time frame	Description
Lipid parameters	Baseline	Different fractions of lipids in the blood including LDL-cholesterol, HDL cholesterol, triglycerides and their subfractions

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026