Obesity, Hypertriglyceridemia, Insulin Resistance, Hypertension
Conditions
Keywords
Fish oil, Omega-3 fatty acids, Metabolic syndrome, Adults
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.
Interventions
DIETARY_SUPPLEMENTFish Oil
Fish oil capsule
DIETARY_SUPPLEMENTFlaxseed Oil
Flaxseed oil capsule
DIETARY_SUPPLEMENTPlacebo
Soybean oil capsule
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 triglycerides at 8 weeks. | Baseline and 8 weeks | Change was calculated as the value at 8 weeks minus the value at baseline |
Countries
United States
Outcome results
None listed