Objective: Our main objective is to evaluate the additional effect of omega-3 fatty acids on maximal walking distance in patients with IC receiving SET. Our secondary objective is to evaluate the effect of omega-3 fatty acids on hemorheological…
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the change in maximal walking distance after 12
weeks of SET.
Secondary outcome
Secondary study parameters are hemorheological parameters: erythrocyte
deformability and aggregation, blood and plasma viscosity and clinical outcome
parameters: change in pain free walking distance, Ankle Brachial Index, blood
pressure and heart rate, perceived walking impairment, visceral fat mass,
sublingual microcirculation, laboratory measures of total, HDL- and LDL
cholesterol and triglycerides, erythrocyte membrane fatty acid compositon, and
ex vivo whole blood cytokine production after stimulation with LPS.
Background summary
Intermittent claudication (IC) is caused by peripheral arterial disease and
has a high morbidity and mortality. Etiologic factors are similar to those of
cardiovascular disease. Primary treatment consists of cardiovascular risk
management and improvement of functional capacity with supervised exercise
therapy (SET). A potential additional therapy is the administration of fish oil
supplements containing high amounts of omega-3 Poly Unsaturated Fatty Acids
(PUFAs). In earlier clinical and experimental trials omega-3 PUFA*s improved
hemorheological parameters such as erythrocyte deformability and aggregation,
and a number of cardiovascular risk factors. Hemorheological parameters
determine the blood flow in the microcirculation, which is of main importance
in patients with IC since the macrocirculation is compromised. Inflammation is
considered an important etiologic factor in the pathogenesis of atherosclerosis
and contributes to peripheral arterial disease Since omega-3 PUFAs also have a
strong anti-inflammatory effect, they might be effective in patients with IC by
lowering the inflammatory response. In addition, visceral fat rather than
obesity in general has been recognised as etiologic and prognostic factor in
atherosclerosis.
We hypothesise that the administration of omega-3 PUFA*s in patients with IC
has a synergistic effect with SET and improves walking distance after SET, by
improving hemorheological parameters resulting in a better microcirculation.
Second, we hypothesise that omega-3 PUFA*s result in a less pro-inflammatory of
whole blood in response to ex vivo stimulation with endotoxin. Third, we
hypothesise that omega-3 PUFA*s and SET result in a decrease in visceral fat
mass.
Study objective
Objective: Our main objective is to evaluate the additional effect of omega-3
fatty acids on maximal walking distance in patients with IC receiving SET. Our
secondary objective is to evaluate the effect of omega-3 fatty acids on
hemorheological parameters, ex vivo stimulated cytokine production and other
clinical outcome parameters.
Study design
A prospective, randomized, open label intervention study.
Intervention
One group receives omega-3 fatty acids (fish oil capsules, 1 capsule 2 times a
day) and one group is the control group. Both groups receive the same standard
care regimen.
Study burden and risks
The burden and risks of this study are associated with the administration of
omega-3 fatty acids and the venous blood samples that will be drawn at the
designated time points. The expected benefit of omega-3 fatty acids affects
hemorheological parameters, clinical outcome parameters and cardiovascular risk
factors.
Wilhelminalaan 12
Alkmaar 1815 JD
NL
Wilhelminalaan 12
Alkmaar 1815 JD
NL
Listed location countries
Age
Inclusion criteria
*Age * 18
*Newly diagnosed intermittent claudication
*Ankle Brachial Index < 0.8 at rest or > 0.15 decrease after exercise
*Able to perform standardized treadmill walking test for 2 min
*Written informed consent
Exclusion criteria
*Unable to fill out a questionnaire (cognitive impairment or insufficient knowledge of the Dutch language)
*Heart failure or unstable cardiac status (angina pectoris NYHA class III or IV or recent myocardial infarction < 3 months)
*Any illness with rapid evolution or a life expectancy < 3 months
*Recent cerebrovascular accident (< 3 months)
*Current use of fish oil supplements or > 2 times a week dietary fish
*Pregnancy
*Fish, soybean or peanut allergy
*Contra indications for the use of omega-3 fatty acids
- Use of oral anti-coagulants (coumarin derivatives)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-004342-42-NL |
| CCMO | NL46719.029.13 |