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

NCT ID: NCT02152930

Last Updated: 2018-07-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-02-29

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.

Conditions

Intermittent Claudication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Supervised Exercise Therapy

Standard treatment: Supervised Exercise Therapy during 12 weeks

Group Type: ACTIVE_COMPARATOR

Omega-3 fatty acids

Intervention Type: DRUG

1000 mg of omega-3 fatty acid ethylesters, 2 times daily, for 4 weeks, followed by 12 weeks of supervised exercise therapy in combination with 2 times daily omega-3 fatty acid supplementation.

Controlled group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Omega-3 fatty acids

1000 mg of omega-3 fatty acid ethylesters, 2 times daily, for 4 weeks, followed by 12 weeks of supervised exercise therapy in combination with 2 times daily omega-3 fatty acid supplementation.

Intervention Type: DRUG

Other Intervention Names

Fish oil supplements

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical Center Alkmaar

OTHER

Sponsor Role: lead

Responsible Party

Alexander P.J. Houdijk

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexander P.J. Houdijk, Dr.

Role: PRINCIPAL_INVESTIGATOR

Medical Center Alkmaar

Locations

Medical Center Alkmaar

Alkmaar, North Holland, Netherlands

Countries

Netherlands

Other Identifiers

NL46719.029.13

Identifier Type: -

Identifier Source: org_study_id