Intermittent Claudication Clinical Trial
Official title:
The Effects of Fish Oil Supplements During Supervised Exercise Therapy in Patients With Intermittent Claudication
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 an 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 proinflammatory 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.
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