Study of the Effects of Blackcurrant Extract and Omega-3 Fats on the Health of the Heart and Blood Vessels

Launched by NATIONAL INSTITUTE OF NURSING RESEARCH (NINR) · Dec 20, 2013

Keywords

ClinConnect Summary

Numerous studies have shown the beneficial effects of fruits, vegetables and omega-3 fatty acids in reducing the risk of cardiovascular disease. The cardioprotective properties may be attributed to the bioactive compounds found in fruits and vegetables called flavonoids. High concentrations of flavonoids with antioxidant activity are found in blackcurrant extract. Flavonoids like omega-3 fatty acids may improve vascular function by increasing the bioavailability of nitric oxide, a potent vasodilator. PCSO-524 (Pernacanaliculus supercritical oil) is of particular interest as a rich source of...

Gender

ALL

Eligibility criteria

• • INCLUSION CRITERIA
• • Men and women between the ages of 55-75 years
• • In general good health as determined by screening evaluation
• • Normal or pre-hypertensive blood pressure (e.g. Systolic less than or equal to 139 mm Hg and Diastolic less than or equal to 89 mm Hg
• • Normal or mild hyperlipidemia (e. g. Total Cholesterol less than or equal to 239, LDL less than or equal to 159, Triglycerides less than or equal to 199, HDL less than or equal to 40 mg/dL)
• • BMI between 18.5 to 25 kg/m\^2
• • Willingness and ability to give consent
• • Willingness to make time commitment for the study
• • EXCLUSION CRITERIA
• • Progressive or unstable disease of any body system including cardiovascular, pulmonary, gastrointestinal, central nervous system, psychiatric, endocrine, hematologic, renal or immunologic disorders
• • Known acute or chronic inflammatory disease ( e.g. rheumatoid arthritis, systemic lupus erythematosus, hepatitis)
• • Elevated C-reactive protein (CRP) level \> 3.0 mg/L
• • Elevated fasting blood glucose level \> 120 mg/dL
• • Elevated lipid profile : Total cholesterol \> 239 mg/dL, Triglycerides \> 200 mg/dL, LDL \>160mg/dL
• • Abnormal complete blood count (CBC): White Blood Cell Count \< 4 or \> 10 K/uL, Red Blood Cell Count \< 4 or \> 7 M/uL, Hemoglobin \< 13 or \> 18 g/dL, Hematocrit \< 39 or \> 52%
• • Recent or ongoing alcohol or drug abuse (Subjects with moderate alcohol consumption described as 12oz. of beer, 5oz. glasses of wine, or 1.5 glasses of hard liquor/day or greater alcohol consumption will be excluded.)
• • Known sensitivity or allergy to fish oil, or shell fish
• • Smoking any tobacco products (cigarettes, pipe, etc.)
• • Subjects currently taking fish oil supplements (participation is possible after 2 month washout period)
• • Subjects taking blood thinners (i.e., Coumadin, warfarin etc.)
• • Subjects with bleeding disorders (i.e., hemophilia)
• • Subjects taking cholesterol-lowering, anti-hypertensive, thyroid or hormonal medications
• • Subjects taking aspirin, non-steroidal anti-inflammatory (NSAIDS) medications or fish oil on a regular basis unless they were discontinued 14 days prior to their first visit.
• • Subjects starting cholesterol-lowering, anti-hypertensive, thyroid or hormonal medications or fish oil during the study
• • Subjects taking supplements unless they were discontinued 14 days prior to their first visit.