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

Sponsor

University of California, San Francisco (Other)

Overall Status

Terminated

CT.gov ID

NCT01412216

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Endothelial Dysfunction Insulin Resistance Metabolic Syndrome Peripheral Arterial Disease	Dietary Supplement: Fish Oil (Omega-3 Fatty Acids) Dietary Supplement: Fish Oil (Omega-3 Fatty Acids)	Phase 2

Study Design

Study Type:

Interventional

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 :

Sep 1, 2011

Actual Primary Completion Date :

Nov 1, 2013

Actual Study Completion Date :

Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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
Placebo Comparator: Placebo Placebo control	Dietary Supplement: Fish Oil (Omega-3 Fatty Acids)

Arm

Intervention/Treatment

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

Placebo Comparator: Placebo

Placebo control

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

Outcome Measures

Primary Outcome Measures

Endothelial Function [5 days]
Flow-mediated, brachial artery vasodilation (FMD)

Secondary Outcome Measures

Insulin Resistance [5 days]
The homeostatic model assessment (HOMA) method used to quantify insulin resistance (HOMA-IR)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

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.