The Effects of Omega-3 Fatty Acids on Metabolic Syndrome

NCT00350194

Last updated date
Study Location
Northwest Lipid Research Clinic (University of Washington Affiliated)
Seattle, Washington, 98104, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metabolic Syndrome X
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Metabolic Syndrome XThe Effects of Omega-3 Fatty Acids on Metabolic Syndrome
NCT00350194
  1. Seattle, Washington
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE The Effects of Omega-3 Fatty Acids on Metabolic Syndrome
Official Title  ICMJE Pilot Study: The Effects of Omega-3 Fatty Acids on Metabolic Syndrome and Vascular Structure in Metabolic Syndrome as Assessed by Carotid IMT
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.
Detailed Description This translational pilot study will have a double-blind, placebo-controlled, parallel design. We will enroll one hundred subjects who meet at least 3 of the 5 criteria for metabolic syndrome as per NCEP guidelines/WHO guidelines and who do not have known cardiovascular disease or diabetes. They will receive either placebo or omega-3 fatty acids in the form of fish oil capsules for a two-year period. Assessment of, C-IMT, serum lipoprotein profile, LDL- buoyancy, adiponectin, CRP, SAA, apolipoprotein B and A-1, fasting glucose, fasting insulin levels, and plasma fatty acids will be measured at baseline, one year, and two years.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Metabolic Syndrome X
Intervention  ICMJE Dietary Supplement: Omega-3 fatty acids
Total of 1.8 grams of EPA +DHA in the form of fish oil capsules (3/day)
Other Name: Fish Oil
Study Arms  ICMJE Placebo Comparator: 1
Omega-3 fatty acid vs. placebo comparator
Intervention: Dietary Supplement: Omega-3 fatty acids
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 11, 2007)
100
Original Enrollment  ICMJE
 (submitted: July 6, 2006)
80
Estimated Study Completion Date  ICMJE June 2012
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00350194
Other Study ID Numbers  ICMJE 28791-D
05-8693-D 03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pathmaja Paramsothy, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE
  • Pfizer
  • National Institutes of Health (NIH)
  • Northwest Lipid Research Clinic
Investigators  ICMJE
Principal Investigator:Pathmaja Paramsothy, MDUniversity of Washington
PRS Account University of Washington
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP