The Effects of Sedentarism on Vascular Function, Inflammation, and Insulin Resistance

Study Overview
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Brief Summary
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The purpose of this study are twofold: To understand the effects of physical inactivity (sedentarism) on vascular function, insulin resistance and inflammation; To assess the role of a dietary intervention (fish oil) in counteracting the effects of physical inactivity on vascular function and inflammation.

Official Title
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The Effects of Sedentarism on Vascular Function, Inflammation, and Insulin Resistance

Conditions
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Endothelial Dysfunction, Insulin Resistance, Metabolic Syndrome, Peripheral Arterial Disease

Intervention / Treatment
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* Dietary Supplement: Fish Oil (Omega-3 Fatty Acids)
* Dietary Supplement: Fish Oil (Omega-3 Fatty Acids)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects: Subjects must be free from any acute, chronic or debilitating medical conditions. Healthy status will be established on the basis of clinical history, electrocardiogram, clinical biochemical screening tests of blood and urine, a physical examination, and where necessary a chest radiograph. Exclusion Criteria: Any active acute or chronic medical problem: Any subject with symptoms of active illness (e.g., fever, leukocytosis, hypertension) will be excluded from study. The exclusion criteria will also include history or evidence for psychiatric disorders, hypertension, diabetes, coronary artery disease (CAD), renal insufficiency, thyroid disease, alcohol or drug abuse, viral hepatitis, deep venous thrombosis or anemia. Individuals with a history of psychiatric illnesses or psychiatric disorders will also be excluded, such as alcoholism, drug dependency including dependency on tobacco, major mood disorders such as major depression and manic depressive illness, schizophrenic disorders, anxiety disorders including panic disorder, generalized anxiety disorder, post traumatic stress disorder, obsessive compulsive disorder, agoraphobia, claustrophobia, paranoid personality disorder, schizoid personality disorder, schizotypal personality disorder, borderline personality disorder, and antisocial personality disorder. In addition, potential subjects with a first order relative with a history of major depressive illness, manic depressive illness, schizophrenia, agoraphobia or panic disorder will also be excluded from entry to this study. Finally, individuals who are unaware of specific psychiatric diagnoses who have a history of having been treated with antidepressant, neuroleptic medications or major tranquilizers will be excluded from study. However, a personal history of limited prior counseling or psychotherapy (e.g., for adjustment reactions) will not necessarily be exclusionary.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fish Oil (Omega-3 Fatty Acids)<br>High-dose, short-duration dietary omega-3 fatty acids supplementation | Dietary Supplement: Fish Oil (Omega-3 Fatty Acids)<br>* fish oil-4.4gm/day x 5 days<br>|
| Placebo Comparator: Placebo<br>Placebo control | Dietary Supplement: Fish Oil (Omega-3 Fatty Acids)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial Function | Flow-mediated, brachial artery vasodilation (FMD) | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Resistance | The homeostatic model assessment (HOMA) method used to quantify insulin resistance (HOMA-IR) | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sedentarism, Physical inactivity, Fish oil, Omega-3 fatty acids, Endothelial dysfunction, Insulin resistance, Metabolic syndrome, peripheral arterial disease