Study of the Effects of Blackcurrant Extract and Omega-3 Fats on the Health of the Heart and Blood Vessels
| Status: | Recruiting |
|---|---|
| Conditions: | High Cholesterol, Peripheral Vascular Disease, Cardiology, Women's Studies |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Reproductive |
| Healthy: | No |
| Age Range: | 55 - 75 |
| Updated: | 4/22/2017 |
| Start Date: | December 10, 2013 |
| End Date: | December 3, 2018 |
| Contact: | Karen Taylor, R.N. |
| Email: | karen.taylor2@nih.gov |
| Phone: | (301) 451-5952 |
Effects of Dietary Blackcurrant Extract and PCSO-524 (PernaCanaliculus Supercritical Oil) on Endothelial Function and Biomarkers of Vascular Health
Background:
- Heart disease is the leading cause of death in the United States. Eating fruits and
vegetables with chemicals called flavonoids may protect against heart disease and improve
blood flow to the heart. They are found in blackcurrant berries. Oils found in fish and
mussels called omega-3 fats have also been shown to protect the heart. Researchers want to
know if blackcurrant extract and omega-3 fats can improve blood flow, which may increase
blood to the heart. They also want to learn about the health of blood vessels and how the
heart works.
Objective:
- To learn if blackcurrant extract and omega-3 fats will improve blood flow and make the
heart beat stronger.
Eligibility:
- Healthy adults 55 to 75 years old.
Design:
- Participants will be screened with medical history, physical exam, and blood tests.
- Visit 1 will take 6 7 hours.
- Participants will have physical exam and blood and urine tests.
- A small device like a microphone will be placed on their arm to take pictures of blood
vessels. A blood pressure cuff will be tightened on their arm and more pictures will be
taken.
- Blood pressure cuffs will be placed on their arms and legs. They will be tightened at
the same time and blood pressure will be measured.
- Participants will answer questions about their eating and exercise.
- Every 8 weeks, participants switch from taking blackcurrant and/or omega-3 tablets to a
placebo to no tablets.
- Every 8 weeks, they will have another shorter clinic visit that will repeat most of
visit 1.
- Heart disease is the leading cause of death in the United States. Eating fruits and
vegetables with chemicals called flavonoids may protect against heart disease and improve
blood flow to the heart. They are found in blackcurrant berries. Oils found in fish and
mussels called omega-3 fats have also been shown to protect the heart. Researchers want to
know if blackcurrant extract and omega-3 fats can improve blood flow, which may increase
blood to the heart. They also want to learn about the health of blood vessels and how the
heart works.
Objective:
- To learn if blackcurrant extract and omega-3 fats will improve blood flow and make the
heart beat stronger.
Eligibility:
- Healthy adults 55 to 75 years old.
Design:
- Participants will be screened with medical history, physical exam, and blood tests.
- Visit 1 will take 6 7 hours.
- Participants will have physical exam and blood and urine tests.
- A small device like a microphone will be placed on their arm to take pictures of blood
vessels. A blood pressure cuff will be tightened on their arm and more pictures will be
taken.
- Blood pressure cuffs will be placed on their arms and legs. They will be tightened at
the same time and blood pressure will be measured.
- Participants will answer questions about their eating and exercise.
- Every 8 weeks, participants switch from taking blackcurrant and/or omega-3 tablets to a
placebo to no tablets.
- Every 8 weeks, they will have another shorter clinic visit that will repeat most of
visit 1.
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 omega-3 fatty acids derived
from the green-lipped mussel. The objectives of this study are to determine the effects of
blackcurrant extract, PCSO-524 or the combination of blackcurrant extract & PCSO-524 on
endothelial function (flow-mediated brachial artery dilation) and arterial stiffness
(cardioankle vascular index) as indicators of cardiovascular risk and atherosclerosis. These
indices also provide an assessment of structure and function of the artery. The effects of
the supplements on biomarkers of vascular health (endothelial dysfunction, inflammation,
injury, oxidative stress, nitric oxide status), lipids and fatty acid profile, and flavonoid
profiles will also be determined. In a randomized, double-blind, placebo-controlled trial,
122 healthy older adults (ages 55-75) will be given either blackcurrant extract (1000 mg),
PCSO-524 (400 mg), or blackcurrant extract (1000 mg) & PCSO-524 (400 mg) daily for 8 weeks
while consuming their usual diet. The study will include 4 visits at 8 week intervals
consisting of treatment, washout and placebo phases.
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 omega-3 fatty acids derived
from the green-lipped mussel. The objectives of this study are to determine the effects of
blackcurrant extract, PCSO-524 or the combination of blackcurrant extract & PCSO-524 on
endothelial function (flow-mediated brachial artery dilation) and arterial stiffness
(cardioankle vascular index) as indicators of cardiovascular risk and atherosclerosis. These
indices also provide an assessment of structure and function of the artery. The effects of
the supplements on biomarkers of vascular health (endothelial dysfunction, inflammation,
injury, oxidative stress, nitric oxide status), lipids and fatty acid profile, and flavonoid
profiles will also be determined. In a randomized, double-blind, placebo-controlled trial,
122 healthy older adults (ages 55-75) will be given either blackcurrant extract (1000 mg),
PCSO-524 (400 mg), or blackcurrant extract (1000 mg) & PCSO-524 (400 mg) daily for 8 weeks
while consuming their usual diet. The study will include 4 visits at 8 week intervals
consisting of treatment, washout and placebo phases.
- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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