Effects of Omega-3 Fatty Acids on Markers of Inflammation

Not Applicable

Completed

Interventions: Dietary Supplement: Fish Oil
Dietary Supplement: Flaxseed Oil
Dietary Supplement: Placebo

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
High-dose Fish Oil	Fish Oil	3.6 g EPA+DHA (2.1 g EPA and 1.5 g DHA) per day
High-dose Flaxseed Oil	Flaxseed Oil	6.6 g ALA (alpha-linolenic acid) per day
Low-dose Fish Oil	Fish Oil	1.2 g EPA+DHA (700 mg EPA and 500 mg DHA) per day
Low-dose Flaxseed Oil	Flaxseed Oil	2.2 g ALA (alpha-linolenic acid) per day
Placebo	Placebo	4 g or 6 g soybean oil per day

Primary Outcome Measures

Name	Time	Method
Change from baseline in inflammatory markers (MCP-1, IL-6, and sICAM-1) at 8 weeks.	Baseline and 8 weeks	Change was calculated as the value at 8 weeks minus the value at baseline

Secondary Outcome Measures

Name	Time	Method
Change from baseline in low-density lipoprotein (LDL) cholesterol at 8 weeks.	Baseline and 8 weeks	Change was calculated as the value at 8 weeks minus the value at baseline
Change from baseline in high-density lipoprotein (HDL) cholesterol at 8 weeks.	Baseline and 8 weeks	Change was calculated as the value at 8 weeks minus the value at baseline
Change from baseline in red blood cells (RBC) Fatty Acids at 8 weeks.	Baseline and 8 weeks	Change was calculated as the value at 8 weeks minus the value at baseline
Change from baseline in triglycerides at 8 weeks.	Baseline and 8 weeks	Change was calculated as the value at 8 weeks minus the value at baseline

Locations (1): Stanford University School of Medicine
🇺🇸
Stanford, California, United States