NCT00350194

Brief Summary

The purpose of this study is to determine the effects of omega-3 fatty acids in the form of fish oil supplementation (approximately 2 grams per day) on the carotid intima-media (CIMT)progression (primary objective) and 2)(Secondary objective) lipid markers such as LDL, apo-B, and LDL buoyancy, on inflammatory burden as measured by CRP, on oxidative stress as measured by urinary isoprostanes, urine microalbumin/creatinine, and serum adiponectin a fat derived hormone in subjects with metabolic syndrome.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Oct 2006

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

March 2, 2012

Status Verified

February 1, 2012

Enrollment Period

5 years

First QC Date

July 6, 2006

Last Update Submit

February 29, 2012

Conditions

Metabolic Syndrome X

Keywords

Fatty Acids, Omega-3

Outcome Measures

Primary Outcomes (1)

  • Change in Carotid IMT

    1 year, 2 years

Secondary Outcomes (7)

  • Lipid (apolipoproteins and lipid parameters)

    1 year, 2 years

  • hs-CRP & SAA

    1 year, 2 years

  • Glucose

    1 year, 2 years

  • Insulin

    1 year, 2 years

  • adiponectin

    1 year, 2 years

  • +2 more secondary outcomes

Study Arms (1)

1

PLACEBO COMPARATOR

Omega-3 fatty acid vs. placebo comparator

Dietary Supplement: Omega-3 fatty acids

Interventions

Omega-3 fatty acidsDIETARY_SUPPLEMENT

Total of 1.8 grams of EPA +DHA in the form of fish oil capsules (3/day)

Also known as: Fish Oil
1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with Metabolic Syndrome (meets 3 of the following 5)
  • Abdominal obesity, waist circumference in men greater than 40 in. \& in women greater than 35 in.
  • Serum triglycerides greater than or = 150 mg/dL (1.7 mmol/L)
  • Serum HDL cholesterol less than or = 40 mg/dL in men and less than 50 mg/dL in women
  • Blood pressure greater than or = 130/85 mmHg or drug treatment for elevated blood pressure
  • Fasting plasma glucose greater than 100 mg/dL

You may not qualify if:

  • Diabetes
  • Known or documented CHD (including ECG consistent with prior MI), CVA (including TIA), PVD (including symptoms of claudication)
  • Angina or other chest pain that may indicate CHD
  • Clinically significant neoplastic, cardiovascular, hepatic, renal, metabolic, endocrine (untreated or unstable), or psychiatric (untreated or unstable)
  • Known abnormal LFTS greater than 2X ULN
  • Smoker, illicit drug use, or excessive alcohol use
  • Medications: Lipid lowering therapy, daily NSAID or greater than 325 mg ASA (PRN use ok), clopidogrel (or equivalent), Coumadin, Omega-3 fatty acid supplement, other investigational drugs within 30 days of study entry, high omega-3 fatty acid content in diet within past three months
  • Pregnancy or planning pregnancy during the study period
  • Sensitivity or allergy to fish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwest Lipid Research Clinic (University of Washington Affiliated)

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Fatty Acids, Omega-3Fish Oils

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsOils

Study Officials

  • Pathmaja Paramsothy, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

July 6, 2006

First Posted

July 10, 2006

Study Start

October 1, 2006

Primary Completion

October 1, 2011

Study Completion

June 1, 2012

Last Updated

March 2, 2012

Record last verified: 2012-02

Locations

US(1)