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

Primary Purpose

Endothelial Dysfunction, Insulin Resistance, Metabolic Syndrome

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fish Oil (Omega-3 Fatty Acids)
Fish Oil (Omega-3 Fatty Acids)
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Endothelial Dysfunction focused on measuring Sedentarism, Physical inactivity, Fish oil, Omega-3 fatty acids, Endothelial dysfunction, Insulin resistance, Metabolic syndrome, peripheral arterial disease

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • University of California San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fish Oil (Omega-3 Fatty Acids)

Placebo

Arm Description

High-dose, short-duration dietary omega-3 fatty acids supplementation

Placebo control

Outcomes

Primary Outcome Measures

Endothelial Function
Flow-mediated, brachial artery vasodilation (FMD)

Secondary Outcome Measures

Insulin Resistance
The homeostatic model assessment (HOMA) method used to quantify insulin resistance (HOMA-IR)

Full Information

First Posted
August 5, 2011
Last Updated
November 6, 2013
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT01412216
Brief Title
The Effects of Sedentarism on Vascular Function, Inflammation, and Insulin Resistance
Acronym
Bedrest
Official Title
The Effects of Sedentarism on Vascular Function, Inflammation, and Insulin Resistance
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Why Stopped
Funding Depleted.
Study Start Date
September 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endothelial Dysfunction, Insulin Resistance, Metabolic Syndrome, Peripheral Arterial Disease
Keywords
Sedentarism, Physical inactivity, Fish oil, Omega-3 fatty acids, Endothelial dysfunction, Insulin resistance, Metabolic syndrome, peripheral arterial disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marlene Grenon, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
Country
United States

12. IPD Sharing Statement

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

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