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

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ClinicalTrials.gov Identifier: NCT02152930
Recruitment Status : Terminated (Low recruitment rate)
First Posted : June 2, 2014
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Alexander P.J. Houdijk, Medical Center Alkmaar

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.


Condition or disease Intervention/treatment Phase
Intermittent Claudication Drug: Omega-3 fatty acids Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Fish Oil Supplements During Supervised Exercise Therapy in Patients With Intermittent Claudication
Actual Study Start Date : December 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Supervised Exercise Therapy
Standard treatment: Supervised Exercise Therapy during 12 weeks
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.
Other Name: Fish oil supplements

No Intervention: Controlled group



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

Secondary Outcome Measures :
  1. Hemorheological parameters [ Time Frame: After 12 weeks of supervised exercise therapy ]
  2. Visceral fat mass [ Time Frame: After 12 weeks of supervised exercise therapy ]
  3. Ex vivo cytokine production after stimulation with lipopolysaccharide [ Time Frame: After 12 weeks of supervised exercise therapy ]
  4. Assessment of the microcirculation with side stream dark field technology [ Time Frame: After 12 weeks of supervised exercise therapy ]

Other Outcome Measures:
  1. Bloodpressure, heart rate, cholesterol, triglycerides, hemoglobin, leucocytes, C-reactive protein, ankle brachial index, [ Time Frame: After 12 weeks of supervised exercise therapy ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152930


Locations
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Netherlands
Medical Center Alkmaar
Alkmaar, Noord Holland, Netherlands, 1800AM
Sponsors and Collaborators
Medical Center Alkmaar
Investigators
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Principal Investigator: Alexander P.J. Houdijk, Dr. Medical Center Alkmaar

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Responsible Party: Alexander P.J. Houdijk, Dr., Medical Center Alkmaar
ClinicalTrials.gov Identifier: NCT02152930    
Other Study ID Numbers: NL46719.029.13
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018
Keywords provided by Alexander P.J. Houdijk, Medical Center Alkmaar:
Fish oil supplements
Supervised Exercise Training
Walking distance
Hemorheological factors
Cardiovascular risk
Additional relevant MeSH terms:
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Intermittent Claudication
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms