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

NCT02152930 | Terminated Phase 3 DMC

• 1 other identifier: NL46719.029.13
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Keywords

Fish oil supplements; Supervised Exercise Training; Walking distance; Hemorheological factors; Cardiovascular risk

Outcome Measures

Primary Outcomes (1)

• Maximal walking distance with standardised treadmill test

  After 12 weeks of supervised exercise therapy

Secondary Outcomes (4)

• Hemorheological parameters

  After 12 weeks of supervised exercise therapy

• Visceral fat mass

  After 12 weeks of supervised exercise therapy

• Ex vivo cytokine production after stimulation with lipopolysaccharide

  After 12 weeks of supervised exercise therapy

• Assessment of the microcirculation with side stream dark field technology

  After 12 weeks of supervised exercise therapy

Other Outcomes (1)

• Bloodpressure, heart rate, cholesterol, triglycerides, hemoglobin, leucocytes, C-reactive protein, ankle brachial index,

  After 12 weeks of supervised exercise therapy

Study Arms (2)

Supervised Exercise Therapy

ACTIVE COMPARATOR

Standard treatment: Supervised Exercise Therapy during 12 weeks

Drug: Omega-3 fatty acids

Controlled group

NO INTERVENTION

Interventions

Omega-3 fatty acids 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.

Also known as: Fish oil supplements

Supervised Exercise Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical Center Alkmaar: lead

Study Sites (1)

Medical Center Alkmaar

Alkmaar, North Holland, 1800AM, Netherlands

Location

MeSH Terms

Conditions

Intermittent Claudication

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Alexander P.J. Houdijk, Dr.

  Medical Center Alkmaar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 28, 2014
• First Posted: June 2, 2014
• Study Start: December 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: July 31, 2018

Record last verified: 2018-07

Locations

NL (1)