The Effects of Fish Oil Supplements During Supervised Exercise Therapy in Patients With Intermittent Claudication (FISHTIC)
Primary Purpose
Intermittent Claudication
Status
Terminated
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Omega-3 fatty acids
Sponsored by
About this trial
This is an interventional treatment trial for Intermittent Claudication focused on measuring Fish oil supplements, Supervised Exercise Training, Walking distance, Hemorheological factors, Cardiovascular risk
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)
Sites / Locations
- Medical Center Alkmaar
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Supervised Exercise Therapy
Controlled group
Arm Description
Standard treatment: Supervised Exercise Therapy during 12 weeks
Outcomes
Primary Outcome Measures
Maximal walking distance with standardised treadmill test
Secondary Outcome Measures
Hemorheological parameters
Visceral fat mass
Ex vivo cytokine production after stimulation with lipopolysaccharide
Assessment of the microcirculation with side stream dark field technology
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02152930
Brief Title
The Effects of Fish Oil Supplements During Supervised Exercise Therapy in Patients With Intermittent Claudication
Acronym
FISHTIC
Official Title
The Effects of Fish Oil Supplements During Supervised Exercise Therapy in Patients With Intermittent Claudication
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Low recruitment rate
Study Start Date
December 2014 (Actual)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical Center Alkmaar
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Claudication
Keywords
Fish oil supplements, Supervised Exercise Training, Walking distance, Hemorheological factors, Cardiovascular risk
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supervised Exercise Therapy
Arm Type
Active Comparator
Arm Description
Standard treatment: Supervised Exercise Therapy during 12 weeks
Arm Title
Controlled group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Omega-3 fatty acids
Other Intervention Name(s)
Fish oil supplements
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximal walking distance with standardised treadmill test
Time Frame
After 12 weeks of supervised exercise therapy
Secondary Outcome Measure Information:
Title
Hemorheological parameters
Time Frame
After 12 weeks of supervised exercise therapy
Title
Visceral fat mass
Time Frame
After 12 weeks of supervised exercise therapy
Title
Ex vivo cytokine production after stimulation with lipopolysaccharide
Time Frame
After 12 weeks of supervised exercise therapy
Title
Assessment of the microcirculation with side stream dark field technology
Time Frame
After 12 weeks of supervised exercise therapy
Other Pre-specified Outcome Measures:
Title
Bloodpressure, heart rate, cholesterol, triglycerides, hemoglobin, leucocytes, C-reactive protein, ankle brachial index,
Time Frame
After 12 weeks of supervised exercise therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander P.J. Houdijk, Dr.
Organizational Affiliation
Medical Center Alkmaar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Center Alkmaar
City
Alkmaar
State/Province
Noord Holland
ZIP/Postal Code
1800AM
Country
Netherlands
12. IPD Sharing Statement
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The Effects of Fish Oil Supplements During Supervised Exercise Therapy in Patients With Intermittent Claudication
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