Effects of Omega-3 Fatty Acids on Markers of Inflammation
NCT ID: NCT01129050
Last Updated: 2023-02-22
Study Results
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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COMPLETED
NA
102 participants
INTERVENTIONAL
2007-04-30
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Low-dose Flaxseed Oil
2.2 g ALA (alpha-linolenic acid) per day
Flaxseed Oil
Flaxseed oil capsule
High-dose Flaxseed Oil
6.6 g ALA (alpha-linolenic acid) per day
Flaxseed Oil
Flaxseed oil capsule
Low-dose Fish Oil
1.2 g EPA+DHA (700 mg EPA and 500 mg DHA) per day
Fish Oil
Fish oil capsule
High-dose Fish Oil
3.6 g EPA+DHA (2.1 g EPA and 1.5 g DHA) per day
Fish Oil
Fish oil capsule
Placebo
4 g or 6 g soybean oil per day
Placebo
Soybean oil capsule
Interventions
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Fish Oil
Fish oil capsule
Flaxseed Oil
Flaxseed oil capsule
Placebo
Soybean oil capsule
Eligibility Criteria
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Inclusion Criteria
* Age: \> or = 18 years
* Ethnicity and race: All ethnic and racial backgrounds welcome
* As defined in ATP III of the National Cholesterol Education program, the metabolic syndrome will be diagnosed as presence of at least three of the following, which will be measured at the screening clinic visit:
Central obesity as measured by waist circumference:
* Men: Greater than 40 inches
* Women: Greater than 35 inches
* Fasting blood triglycerides greater than or equal to 150 mg/dL
* Blood HDL cholesterol:
* Men: Less than 40 mg/dL
* Women: Less than 50 mg/dL
* Blood pressure greater than or equal to 130/85 mmHg
* Fasting glucose greater than or equal to 100 mg/dL
Planning to be available for clinic visits and bottle pick-ups for the 8 weeks of study participation
Ability and willingness to give written informed consent
No known active psychiatric illness.
Exclusion Criteria
* Significant liver enzyme abnormality
* AST or ALT more than 2 times the upper limit of normal and/or
* Bilirubin more than 50% the upper limit of normal
* Renal disease as measured at baseline:
* Serum creatinine \> 1.30 mg/dL, or
* Calculated creatinine clearance \< 71 mL/min
* Self reported personal history of:
* Clotting disorders
* Clinically significant atherosclerosis (e.g., CAD, PAD)
* Malignant neoplasm
* Ongoing infection
* Inflammatory disease (e.g., rheumatoid arthritis)
* Subjects currently receiving the following medications (self report):
* Anti-Inflammatory drugs
* Lipid lowering drugs including statins
* Anti-hypertensive drugs
* Anti-coagulant drugs
* Body Mass Index (BMI) greater than or equal to 40.
* Pregnant or Lactating
* Inability to communicate effectively with study personnel
18 Years
ALL
Yes
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
Stanford University
OTHER
Responsible Party
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Christopher Gardner
Professor of Medicine (Research)
Principal Investigators
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Christopher D Gardner
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University School of Medicine
Stanford, California, United States
Countries
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References
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Dewell A, Marvasti FF, Harris WS, Tsao P, Gardner CD. Low- and high-dose plant and marine (n-3) fatty acids do not affect plasma inflammatory markers in adults with metabolic syndrome. J Nutr. 2011 Dec;141(12):2166-71. doi: 10.3945/jn.111.142240. Epub 2011 Oct 26.
Related Links
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Study description and summary of results
Other Identifiers
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SU-05042010-5842
Identifier Type: -
Identifier Source: org_study_id
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