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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02019680
• Date of registration: 20/12/2013
• Prospective Registration: No
• Primary sponsor: National Institute of Nursing Research (NINR)
• Public title: Study of the Effects of Blackcurrant Extract and Omega-3 Fats on the Health of the Heart and Blood Vessels
• Scientific title: Effects of Dietary Blackcurrant Extract and PCSO-524 (PernaCanaliculus Supercritical Oil) on Endothelial Function and Biomarkers of Vascular Health
• Date of first enrolment: December 10, 2013
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02019680
• Study type: Observational
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Marguerite M Engler, Ph.D.
• Affiliation: National Institute of Nursing Research (NINR)

Key inclusion & exclusion 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.



Age minimum: 55 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Arteriosclerosis

Cardiovascular Disease

Abnormalities

Hyperlipidemia

Primary Outcome(s)

Endothelial function (flow-mediated brachial artery dilation) and arterial stiffness (cardio-ankle vascular index) [Time Frame: 8 weeks x 4]

Secondary Outcome(s)

Biomarkers of vascular health (endothelial dysfunction, inflammation, injury, oxidative stress, nitric oxide status), lipids and fatty acid profile, and flavonoid profiles [Time Frame: 8 weeks x 4]

Secondary ID(s)

140034

14-NR-0034

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Tufts University