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Effects of Mediterranean Diet and Omega-3 Fatty Acids on Oxidative Stress and EPC's

Phase 2
40 Years
65 Years
Not Enrolling

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Trial Information

Effects of Mediterranean Diet and Omega-3 Fatty Acids on Oxidative Stress and EPC's

Inclusion Criteria:

- Body mass index [BMI; body weight (kg)/height (m)2] greater than or equal to 28 and
less than 35

- Stable body weight in the past 6 months (weight change < 2 kg)

- Non-smokers

- Currently consuming a stable habitual diet as assessed by interview with a
nutritionist and 24 hour diet recall showing:

- saturated + trans fat intake of > 10% of total daily calories; and

- total cholesterol intake of > 300 mg/day

- Not consuming antioxidants or vitamin-mineral preparations in the last 4 weeks

Exclusion Criteria:

- History of significant cardiovascular disease

- Cancer other than remote history of skin cancer

- Diabetes mellitus by history or fasting plasma glucose (FPG) > 126mg/dL

- Excessive chronic alcohol consumption (averaging > two alcoholic beverages/day)

- Known acute or chronic illness, including psychiatric problems that will, in the
opinion of the principal investigator (PI), make one ineligible for the study

- Statin or other hypolipidemic therapy

- Current intake of vitamins and supplements

- Inability to return to Emory for follow-up, blood drawing

- Pregnant or lactating females

- Unable to give informed consent

- Hematocrit < 30%

- Uncontrolled hypertension with systolic blood pressure (SBP) > 180 and diastolic
blood pressure (DBP) > 110

- History of bleeding disorder

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Brachial artery reactivity to test flow-mediated vasodilation (FMD) as a measure of endothelial function.

Outcome Time Frame:

4 Weeks

Safety Issue:


Principal Investigator

Arshed A Quyyumi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University


United States:Emory IRB

Study ID:




Start Date:

December 2004

Completion Date:

July 2006

Related Keywords:

  • Obesity
  • Oxidative Stress
  • Diet, Mediterranean
  • Obesity



Emory University HospitalAtlanta, Georgia  30322