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

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.

Study Overview

• Status: Terminated
• Conditions: Peripheral Arterial Disease; Metabolic Syndrome; Insulin Resistance; Endothelial Dysfunction
• Intervention / Treatment: Dietary supplement: Fish Oil (Omega-3 Fatty Acids); Dietary supplement: Fish Oil (Omega-3 Fatty Acids)

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States
      • University of California San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Marlene Grenon, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: August 5, 2011
• First Submitted That Met QC Criteria: August 8, 2011
• First Posted (Estimate): August 9, 2011

Study Record Updates

• Last Update Posted (Estimate): November 7, 2013
• Last Update Submitted That Met QC Criteria: November 6, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Endothelial dysfunction; Metabolic syndrome; Insulin resistance; Physical inactivity; Omega-3 fatty acids; Fish oil; peripheral arterial disease; Sedentarism
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Hyperinsulinism; Inflammation; Peripheral Arterial Disease; Peripheral Vascular Diseases; Metabolic Syndrome; Insulin Resistance
• Other Study ID Numbers: Sedentarism