The Effects of Sedentarism on Vascular Function, Inflammation, and Insulin Resistance (Bedrest)
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ClinicalTrials.gov Identifier: NCT01412216 |
Recruitment Status :
Terminated
(Funding Depleted.)
First Posted : August 9, 2011
Last Update Posted : November 7, 2013
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Endothelial Dysfunction Insulin Resistance Metabolic Syndrome Peripheral Arterial Disease | Dietary Supplement: Fish Oil (Omega-3 Fatty Acids) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 5 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | The Effects of Sedentarism on Vascular Function, Inflammation, and Insulin Resistance |
Study Start Date : | September 2011 |
Actual Primary Completion Date : | November 2013 |
Actual Study Completion Date : | November 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Fish Oil (Omega-3 Fatty Acids)
High-dose, short-duration dietary omega-3 fatty acids supplementation
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Dietary Supplement: Fish Oil (Omega-3 Fatty Acids)
fish oil-4.4gm/day x 5 days |
Placebo Comparator: Placebo
Placebo control
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Dietary Supplement: Fish Oil (Omega-3 Fatty Acids) |
- Endothelial Function [ Time Frame: 5 days ]Flow-mediated, brachial artery vasodilation (FMD)
- Insulin Resistance [ Time Frame: 5 days ]The homeostatic model assessment (HOMA) method used to quantify insulin resistance (HOMA-IR)

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

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): NCT01412216
United States, California | |
University of California San Francisco | |
San Francisco, California, United States |
Principal Investigator: | Marlene Grenon, MD | University of California, San Francisco |
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT01412216 |
Other Study ID Numbers: |
Sedentarism |
First Posted: | August 9, 2011 Key Record Dates |
Last Update Posted: | November 7, 2013 |
Last Verified: | November 2013 |
Sedentarism Physical inactivity Fish oil Omega-3 fatty acids |
Endothelial dysfunction Insulin resistance Metabolic syndrome peripheral arterial disease |
Peripheral Arterial Disease Peripheral Vascular Diseases Metabolic Syndrome Insulin Resistance Inflammation Pathologic Processes Hyperinsulinism |
Glucose Metabolism Disorders Metabolic Diseases Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |