Clinical trial NCT02152930: The Effects of Fish Oil Supplements During Supervised Exercise Therapy in Patients With Intermittent Claudication
Official title: The Effects of Fish Oil Supplements During Supervised Exercise Therapy in Patients With Intermittent Claudication
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Intermittent Claudication
Keywords: Fish oil supplements
Supervised Exercise Training
Walking distance
Hemorheological factors
Cardiovascular risk
Lead sponsor: Medical Center Alkmaar
Sponsor class: OTHER
First posted: 2014-06-02
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* Newly diagnosed intermittent claudication
* Ankle Brachial Index \< 0.8 at rest or \> 0.15 decrease after exercise
* Able to perform standardised 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 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 anticoagulants (coumarin derivatives)

Primary outcomes:
measure: Maximal walking distance with standardised treadmill test
timeFrame: After 12 weeks of supervised exercise therapy
Secondary outcomes:
measure: Hemorheological parameters
timeFrame: After 12 weeks of supervised exercise therapy
measure: Visceral fat mass
timeFrame: After 12 weeks of supervised exercise therapy
measure: Ex vivo cytokine production after stimulation with lipopolysaccharide
timeFrame: After 12 weeks of supervised exercise therapy
measure: Assessment of the microcirculation with side stream dark field technology
timeFrame: After 12 weeks of supervised exercise therapy
Other outcomes:
measure: Bloodpressure, heart rate, cholesterol, triglycerides, hemoglobin, leucocytes, C-reactive protein, ankle brachial index,
timeFrame: After 12 weeks of supervised exercise therapy
Locations:
city: Alkmaar
country: Netherlands
facility: Medical Center Alkmaar
state: Noord Holland
Study officials:
affiliation: Medical Center Alkmaar
name: Alexander P.J. Houdijk, Dr.
role: PRINCIPAL_INVESTIGATOR
References: