NCT01412216

Brief Summary

The purpose of this study are twofold:

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 9, 2011

Completed
23 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

November 7, 2013

Status Verified

November 1, 2013

Enrollment Period

2.2 years

First QC Date

August 5, 2011

Last Update Submit

November 6, 2013

Conditions

Endothelial DysfunctionInsulin ResistanceMetabolic SyndromePeripheral Arterial Disease

Keywords

SedentarismPhysical inactivityFish oilOmega-3 fatty acidsEndothelial dysfunctionInsulin resistanceMetabolic syndromeperipheral arterial disease

Outcome Measures

Primary Outcomes (1)

  • Endothelial Function

    Flow-mediated, brachial artery vasodilation (FMD)

    5 days

Secondary Outcomes (1)

  • Insulin Resistance

    5 days

Study Arms (2)

Fish Oil (Omega-3 Fatty Acids)

EXPERIMENTAL

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

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

Placebo

PLACEBO COMPARATOR

Placebo control

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

Interventions

Fish Oil (Omega-3 Fatty Acids)DIETARY_SUPPLEMENT

fish oil-4.4gm/day x 5 days

Fish Oil (Omega-3 Fatty Acids)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, United States

Location

MeSH Terms

Conditions

Insulin ResistanceMetabolic SyndromePeripheral Arterial DiseaseSedentary Behavior

Interventions

Fish OilsFatty Acids, Omega-3

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesAtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

OilsLipidsDietary Fats, UnsaturatedDietary FatsFatsFatty Acids, UnsaturatedFatty Acids

Study Officials

  • Marlene Grenon, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2011

First Posted

August 9, 2011

Study Start

September 1, 2011

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

November 7, 2013

Record last verified: 2013-11

Locations

US(1)