Status:
COMPLETED
Effect of a Mediterranean Diet and Omega-3 Fatty Acids on Oxidative Stress and Endothelial Progenitor Cells (EPC's)
Lead Sponsor:
Emory University
Conditions:
Obesity
Eligibility:
All Genders
40-65 years
Phase:
PHASE2
Brief Summary
Problem of Interest: A typical American diet that is high in an intake of fats (especially saturated fats and cholesterol) is known to lead to high blood levels of cholesterol, hardening of the arter...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00166088
Start Date
December 1 2004
End Date
July 1 2006
Last Update
November 18 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Emory University Hospital
Atlanta, Georgia, United States, 30322