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

University of California San Francisco (UCSF) logo

University of California San Francisco (UCSF)

Status and phase

Terminated
Phase 2

Conditions

Endothelial Dysfunction
Insulin Resistance
Peripheral Arterial Disease
Metabolic Syndrome

Treatments

Dietary Supplement: Fish Oil (Omega-3 Fatty Acids)

Study type

Interventional

Funder types

Other

Identifiers

NCT01412216
Sedentarism

Details and patient eligibility

About

The purpose of this study are twofold:

  1. To understand the effects of physical inactivity (sedentarism) on vascular function, insulin resistance and inflammation;
  2. To assess the role of a dietary intervention (fish oil) in counteracting the effects of physical inactivity on vascular function and inflammation.

Enrollment

5 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

5 participants in 2 patient groups, including a placebo group

Fish Oil (Omega-3 Fatty Acids)
Experimental group
Description:
High-dose, short-duration dietary omega-3 fatty acids supplementation
Treatment:
Dietary Supplement: Fish Oil (Omega-3 Fatty Acids)
Dietary Supplement: Fish Oil (Omega-3 Fatty Acids)
Placebo
Placebo Comparator group
Description:
Placebo control
Treatment:
Dietary Supplement: Fish Oil (Omega-3 Fatty Acids)
Dietary Supplement: Fish Oil (Omega-3 Fatty Acids)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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