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

Intermittent Claudication Clinical Trial

— FISHTIC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02152930
• Other study ID #: NL46719.029.13
• Status: Terminated
• Phase: Phase 3
• Start date: December 2014
• Est. completion date: February 2016

Study information

• Verified date: July 2018
• Source: Medical Center Alkmaar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Intermittent Claudication

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Netherlands	Medical Center Alkmaar	Alkmaar	Noord Holland

Sponsors (1)

Lead Sponsor	Collaborator
Medical Center Alkmaar

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bloodpressure, heart rate, cholesterol, triglycerides, hemoglobin, leucocytes, C-reactive protein, ankle brachial index,		After 12 weeks of supervised exercise therapy
Primary	Maximal walking distance with standardised treadmill test		After 12 weeks of supervised exercise therapy
Secondary	Hemorheological parameters		After 12 weeks of supervised exercise therapy
Secondary	Visceral fat mass		After 12 weeks of supervised exercise therapy
Secondary	Ex vivo cytokine production after stimulation with lipopolysaccharide		After 12 weeks of supervised exercise therapy
Secondary	Assessment of the microcirculation with side stream dark field technology		After 12 weeks of supervised exercise therapy