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

NCT ID: NCT01412216

Last Updated: 2013-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Endothelial Dysfunction Insulin Resistance Metabolic Syndrome Peripheral Arterial Disease

Keywords

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Sedentarism Physical inactivity Fish oil Omega-3 fatty acids Endothelial dysfunction Insulin resistance Metabolic syndrome peripheral arterial disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fish Oil (Omega-3 Fatty Acids)

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

Group Type EXPERIMENTAL

Fish Oil (Omega-3 Fatty Acids)

Intervention Type DIETARY_SUPPLEMENT

fish oil-4.4gm/day x 5 days

Placebo

Placebo control

Group Type PLACEBO_COMPARATOR

Fish Oil (Omega-3 Fatty Acids)

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Fish Oil (Omega-3 Fatty Acids)

fish oil-4.4gm/day x 5 days

Intervention Type DIETARY_SUPPLEMENT

Fish Oil (Omega-3 Fatty Acids)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marlene Grenon, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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Sedentarism

Identifier Type: -

Identifier Source: org_study_id