Clinical Trial: The Effects of Fish Oil Supplements During Supervised Exercise Therapy in Patients With Intermittent Claudication

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: The Effects of Fish Oil Supplements During Supervised Exercise Therapy in Patients With Intermittent Claudication

Brief 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 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.


Detailed Summary:
Sponsor: Medical Center Alkmaar

Current Primary Outcome: Maximal walking distance with standardised treadmill test [ Time Frame: After 12 weeks of supervised exercise therapy ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Hemorheological parameters [ Time Frame: After 12 weeks of supervised exercise therapy ]
  • Visceral fat mass [ Time Frame: After 12 weeks of supervised exercise therapy ]
  • Ex vivo cytokine production after stimulation with lipopolysaccharide [ Time Frame: After 12 weeks of supervised exercise therapy ]
  • Assessment of the microcirculation with side stream dark field technology [ Time Frame: After 12 weeks of supervised exercise therapy ]


Original Secondary Outcome: Same as current

Information By: Medical Center Alkmaar

Dates:
Date Received: May 28, 2014
Date Started: December 2014
Date Completion: December 2016
Last Updated: April 25, 2016
Last Verified: September 2015