Effects of Omega-3 Fatty Acids on Markers of Inflammation

Stanford University

Status: Completed

Conditions: Hypertension; Hypertriglyceridemia; Insulin Resistance; Obesity

Treatments: Dietary Supplement: Flaxseed Oil; Dietary Supplement: Placebo; Dietary Supplement: Fish Oil

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01129050

SU-05042010-5842

R21AT003465-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The major purpose of this study is to examine the effect of two sources of dietary omega-3 fatty acids, each given at two doses, on potential health benefits related to cardiovascular disease prevention. The two sources of dietary omega-3 fatty acids will be fish oil, and flaxseed oil.

Full description

The primary aim of this study is to examine the effect of two sources of dietary omega-3 fatty acids, each given at two doses, on potential health benefits related to cardiovascular disease prevention. The two sources of dietary omega-3 fatty acids will be fish oil, and flaxseed oil. Each will be given at a lower dose that could realistically be achieved from food sources alone, and at a higher dose that could not realistically be achieved from food alone and would require supplementation. The outcomes being studied are markers of inflammation. The subjects being studied are those with elevated risk factors for diabetes and heart disease that meet the criteria for the "metabolic syndrome". These are the people who are currently not diabetic, and who have not been diagnosed yet with heart disease, who are at risk of developing these diseases and who would likely benefit the most from the omega-3 therapy should it prove to be effective.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:Gender:

• Both women and men
• 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:Daily intake of dietary supplements containing omega-3 FAs within the past month.

• Fasting blood glucose > 140 mg/dL

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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102 participants in 5 patient groups, including a placebo group

Low-dose Flaxseed Oil

Experimental group

Description:

2.2 g ALA (alpha-linolenic acid) per day

Treatment:

Dietary Supplement: Flaxseed Oil

High-dose Flaxseed Oil

Experimental group

Description:

6.6 g ALA (alpha-linolenic acid) per day

Treatment:

Dietary Supplement: Flaxseed Oil

Low-dose Fish Oil

Experimental group

Description:

1.2 g EPA+DHA (700 mg EPA and 500 mg DHA) per day

Treatment:

Dietary Supplement: Fish Oil

High-dose Fish Oil

Experimental group

Description:

3.6 g EPA+DHA (2.1 g EPA and 1.5 g DHA) per day

Treatment:

Dietary Supplement: Fish Oil

Placebo

Placebo Comparator group

Description:

4 g or 6 g soybean oil per day

Treatment:

Dietary Supplement: Placebo